Devices, systems, and methods for diagnosis and treatment of overactive bladder

ABSTRACT

A system for modulating bladder function is disclosed. A system for evaluating the electrophysiological function of a bladder is disclosed. Methods for performing a controlled surgical procedure on a bladder are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed. An implantable device for monitoring and/or performing a neuromodulation procedure on a bladder is disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a national stage application of InternationalApplication No. PCT/2013/045605 which claims benefit of and priority toU.S. Provisional Application Ser. No. 61/659,463 filed on Jun. 14, 2012,entitled “Devices, systems, and methods for diagnosis and treatment ofoveractive bladder”, by Landy Toth et al., the entire contents of whichare both incorporated by reference herein for all purposes.

BACKGROUND

Technical Field

The present disclosure is directed to systems, devices, and methods forassessing, treating, and monitoring an internal surface of a body (e.g.,an organ wall, a tissue site, etc.). The present disclosure is furtherdirected to systems, devices, and methods for diagnosing and treatingneurological diseases of the bladder.

Background

Urine storage symptoms (e.g., urgency, frequency, and nocturia), with orwithout associated urge incontinence are characterized as overactivebladder (OAB). In subjects with OAB, smooth muscle in the unstablebladders often shows enhanced spontaneous contractile activity. Inaddition, altered responses to electrical stimulation and/or agonistsare seen from the unstable detrusor. The bladder smooth muscle frompatients suffering from unstable bladder demonstrates increased myogenicactivity along with fused tetanic contractions and changes inmorphological structure (increased connective tissue between musclefascicles often associated with local trauma). Sensitization of bladderafferents may lead to enhanced signal transmission along associatedneurons. Furthermore, in genomically predisposed patients (e.g.,patients with familial urge incontinence or chronic pain syndromes), orpatients with long-term environmental changes (e.g., following spinalcord injury, obstruction, inflammation, etc.), nerve growth factor (NGF)may alter afferents irreversibly. Such conditions often lead to a longterm chronic condition for patients that can be difficult to manage.

The overactive bladder (OAB) and urinary incontinence (UI) marketplacefor drug and device based therapies in the United States is an over $12billion a year industry. Prevalence based modeling analyses have shownthe OAB-attributable expenditures in the US to be $65.9 B per year. Theconditions affect over 16 percent of all Americans (projected prevalenceis between 15% and 38%), resulting in approximately 37 million men andwomen living with the OAB in the US. Due to social stigmas attached toOAB and UI, as well as misunderstanding of the signs and symptomsassociated with OAB and UI, only 40 percent of those affected (13.6M)seek treatment. Of those 13.6 million individuals, nearly 30 percent areunsatisfied with their current therapy.

Currently, a range of OAB treatment options are available for patientsor currently under development. Such treatments include anticholinergicagents (antimuscarinic agents), β₃ agonists (sensory inhibition),vanilloid receptor agents (desensitization of C-fiber-afferent neurons),neurokinin-1 receptor antagonists (pathophysiologic sensory signalinginterference), phosphodiesterase-5 inhibitors (symptom relief),botulinum toxin (neuromuscular blocking agents), sacral neuromodulation(surgically implanted stimulation devices), and posterior tibial nervestimulation (externally applied stimulation devices). Treatments to datehave been met with limited success and, as mentioned previously, a largesubset of the patient population is currently unsatisfied with theircurrent therapy.

SUMMARY

One objective of the present disclosure is to provide systems, devices,and methods to for treatment of a disease state in a body (e.g., totreat overactive bladder). Another objective is to provide a system forperforming sympathectomy and/or parasympathectomy on a compliantstructure within a body (e.g., a bladder wall, an intestinal wall,etc.). Yet another objective is to provide systems, devices, and methodsto map, monitor, and/or study electrophysiology of a structure within abody (e.g., a bladder wall, an intestinal wall, etc.).

Another objective is to provide devices, systems, and methods formonitoring local neurological activity along an organ wall and/or toextract spatially fine electrophysiological characteristics from amongstone or more macroscopic biosignals (e.g., to extract local neurologicalsignals from potentially overwhelming electrocardiographic and/orelectromyographic signals), and to predict the spatial origin ofneurological signals (e.g., as part of a neuronal locating and/ormapping system, etc.).

Yet another objective is to provide devices, systems, and methods fordetermining the directivity of local neurological activity, directivityof signal propagation, and/or assessing neurological behavior (e.g.,regular behavior versus rogue behavior) along a surface in a body (e.g.,along a bladder wall, an intestinal wall, etc.).

Another objective is to provide devices, systems, and methods fordetermining the location (i.e., along a surface, depth into a surface,etc.) of one or more anatomical features (e.g., sensory receptor, aneuron, a nerve plexus, etc.) along an organ or cavity wall within abody.

Another objective is to provide devices, systems, and methods forablating local anatomy within a body with physiological feedback before,during, and/or after the procedure to assess the state of completionthereof.

Another objective is to provide devices, systems, and methods forcombined urinary bladder urodynamic testing, neurological assessment,treatment, and/or urodynamic follow up. Such systems, devices, andmethods may be advantageous for substantially optimally treatingdiseased tissue states such as those associated with overactive bladder.

The above objectives are wholly or partially met by devices, systems,and methods described herein. In particular, features and aspects of thepresent disclosure are set forth in the appended claims, followingdescription, and the annexed drawings.

According to a first, aspect there is provided, a surgical tool forneuromodulating bladder function, including an elongate delivery memberconfigured and dimensioned to be inserted into a bladder through aurethra, a therapy delivery element coupled with the delivery member,configured to interface with a tissue in a target region of a bladderwall to provide therapy to the target region; and one or more sensingtips electrically and mechanically coupled with the delivery member,configured to interface with one or more tissue surfaces of the bladderwall and/or the urethra, the sensing tips configured to convey one ormore electrophysiological signals associated with the tissue surfacesbefore, during, and/or after the therapy.

In aspects, the electrophysiological signals may be related to one ormore of water concentration, tissue tone, evoked potential, remotelystimulated nervous activity, a pressure stimulated nervous response, anelectrically stimulated movement, sympathetic nervous activity, anelectromyographic signal [EMG], a mechanomyographic signal [MMG], alocal field potential, an electroacoustic event, vasodialation, bladderwall stiffness, muscle sympathetic nerve activity [MSNA], centralsympathetic drive, nerve traffic, or combinations thereof, or the like.

In aspects, one or more of the sensing tips comprise the therapydelivery element. In aspects, at least one of the tissue surfaces issubstantially coincident with the target region.

In aspects, one or more sensing tips may include one or more electrodesin accordance with the present disclosure configured to interface withthe associated tissue surface. In aspects, one or more of the electrodesmay include embossed, plated, and/or filament loaded structuresthereupon configured to protrude into the associated tissue surface whenbiased there against. In aspects, one or more of the sensing tips may beelectrically coupled with a microcircuit in accordance with the presentdisclosure, the microcircuit configured to condition the signal. Inaspects, the microcircuit is embedded into the surgical tool and atleast a portion of the electrical coupling is provided via the deliverymember. In aspects, one or more sensing tips may include one or moreneedle electrodes and/or one or more whiskers each of which having acharacteristic length and a tip, the needle electrode and/or whiskersarranged so as to extend from the sensing tip into the associated tissuesurface.

In aspects, one or more sensing tips may include a mechanomyographic(MMG) sensing element configured to generate a mechanomyographic signal(MMG) from the associated tissue surface, a compliance sensor,configured to generate a tissue tone signal, and/or a microelectrodeconfigured to interface with the associated tissue surface, themicroelectrode having an area of less than 5000 μm², less than 1000 μm²,less than 250 μm², less than 100 μm², etc.

In aspects, one or more sensing tips and/or the therapy delivery elementmay be configured to stimulate (e.g., electrically stimulate,mechanically stimulate, rub, vibrate, pinch, pressurize, provide acurrent to, etc.) and/or ablate (e.g., thermally ablate, apply RFcurrent thereto, cyroablate, ultrasonically ablate, radiosurgicallyablate, etc.) the associated tissue surface and/or target regionrespectively. In aspects, one or more sensing tips may be configured soas to monitor the effect of the stimulation and/or ablation on thetissue surface and/or target region.

In aspects, the therapy delivery element may be configured fordelivering a therapeutic substance in accordance with the presentdisclosure to the target region. In aspects, one or more of the sensingtips may be configured to monitor the effect of the therapeuticsubstance on the target region.

In aspects, some non-limiting examples of therapeutic substances are achemical, a drug substance, a neuromodulating substance, a neuroblockingsubstance, an acid, a base, a denervating agent, or a combinationthereof, a neurotoxin, a botulinum toxin, a tetrodotoxin, atetraethylammonium, a chlorotoxin, a curare, a conotoxin, abungarotoxin, arsenic, ammonia, ethanol, hexane, nitric oxide,glutamate, resiniferatoxin, alchohol, phenol, capaicin, an anesthetic,lidocaine, tetanus toxin, quaternary ammonium salts, a pachycurare, aleptocurare, acetylcholine, aminosteroids, a combination thereof, or thelike.

In aspects, the delivery member may include a lumen for providing fluidcommunication between the bladder and a fluid source located outside ofthe bladder. In aspects, a therapeutic fluid (i.e., for performinghyperthermia based chemotherapy, etc.) may be provided via the lumen.

In aspects, the surgical tool may include a balloon mechanically coupledto the delivery member, configured and dimensioned to interface with thebladder wall when filled with a fluid. In aspects, one or more of thesensing tips and/or the therapy delivery element may be attached to theballoon and arranged so as to interface with the associated tissuesurface and/or target region upon filling of the balloon. In aspects,the delivery member comprising a lumen, arranged so as to provide fluidcommunication between the balloon and a fluid source positioned outsideof the bladder. In aspects, the lumen may be coupled in fluidcommunication with the balloon, the tool may include a pressure sensorin fluid communication with the balloon, configured to measure theballoon fill pressure during a procedure, and/or one or more sensingtips may be configured to measure an interfacial pressure between theballoon and the associated tissue surface.

In aspects, the therapy delivery element may be configured to deliverthermal energy, radio frequency energy, etc. to the target region.

In aspects, the surgical tool may include a microfinger in accordancewith the present disclosure having a substantially elongate structureand a length, electrically and mechanically coupled with the deliverymember, configured so as to bias at least a portion thereof against thebladder wall upon deployment from within the bladder. In aspects, themicrofinger may include one of the sensing tips, configured to bias thesensing tip towards the bladder wall upon deployment from within thebladder. In aspects, the microfinger may include an electricallyconducting core extending along the length thereof and an electricallyinsulating clad layer surrounding the core. In aspects, the system mayinclude more than 100 microfingers, more than 500 microfingers, morethan 1,000 microfingers, etc.

In aspects, the tool may be configured to deliver a tissue visualizingmedium in accordance with the present disclosure to the target regionand/or one or more of the tissue surfaces. In aspects, the tool may becoupled to a display, configured to convey a visualization of thesignals, the target region, or one or more of the tissue surfaces to auser.

In aspects, the tool may be configured to perform a urodynamic study onthe bladder, one or more of the sensing tips configured to monitor theeffect of urodynamic study on the associated tissue surfaces and/or thetarget region. In aspects, the tool may include a processor, configuredto analyze the signals to generate the target region.

In aspects, the therapy delivery element may be configured to modulateat least one of micturition, incontinence, frequency, pain, nocturia, orbladder capacity, and/or configured to modulate neural activity in atleast a portion of the bladder wall.

According to aspects there is provided, use of a surgical tool inaccordance with the present disclosure, to modulate electrophysiologicalactivity in at least a portion of the bladder or urethra.

According to aspects there is provided, use of a surgical tool inaccordance with the present disclosure, to perform a surgical procedureon a subject.

According to aspects there is provided, use of a microsurgical tool inaccordance with the present disclosure, to treat overactive bladder(OAB), interstitial cystitis (IC), bladder cancer, or ureteral stentpain/voiding dysfunction.

According to aspects there is provided, a method for determining theelectrophysiological function of a bladder, including monitoringelectrophysiological activity at a plurality of sites within the bladderduring a urodynamic test, monitoring one or more of bladder fillpressure or volume during the urodynamic test, and comparing themonitored activity with the fill pressure or volume.

In aspects, the method may include generating a metric from themonitored electrophysiological activity and bladder fill pressure orvolume, the metric being representative of electrophysiological functionof the bladder, comparing activity measured at one of the sites to themetric to determine if the site exhibits abnormal activity, generating amap of the electrophysiological functionality of the bladder from themonitored activity alone or in combination with the metric, and/ordetermining if one or more of the sites would benefit from therapy.

In aspects, the method may include applying a neural block to one ormore of the sites and re-evaluating electrophysiological function of thebladder. In aspects, the method may include comparing activities beforeand after the neural block to determine if a permanent surgicalprocedure is warranted.

In aspects, one or more one or more of the steps of the method may beperformed using a surgical tool in accordance with the presentdisclosure.

According to aspects there is provided, a method to modulate bladderfunction, including monitoring a first electrophysiological activity atone or more sites within the bladder, applying therapy to a targetregion of the bladder, monitoring a second electrophysiological activityat one or more sites within the bladder, and comparing the firstmonitored activity and the second monitored activity to determine if thetherapy was successful.

In aspects, the method may include applying additional therapy to thetarget region and/or applying therapy to an alternative target region ifthe therapy was determined to be unsuccessful, selecting the targetregion based upon the first monitored activity, selecting an alternativetarget region based at least in part upon the second monitoringactivity.

In aspects, the monitored electrophysiological activity may include oneor more of water concentration, tissue tone, evoked potential, remotelystimulated nervous activity, a pressure stimulated nervous response, anelectrically stimulated movement, sympathetic nervous activity, anelectromyographic signal [EMG], a mechanomyographic signal [MMG], alocal field potential, an electroacoustic event, vasodialation, bladderwall stiffness, muscle sympathetic nerve activity [MSNA], centralsympathetic drive, nerve traffic as measured in the vicinity of thebladder, urethra, spine, uterus, or rectum, combinations thereof, or thelike.

In aspects, the method may include mapping electrophysiological activityin the bladder using the first monitored activity, and/or applying astimulus to a tissue in neurological and/or neuromuscular communicationwith the bladder. In aspects, the method may include recordingelectrophysiological activity before, during, and/or after the stimulusto determine the effects thereof on the bladder.

In aspects, the method may include applying a neural block to a regionof the bladder. In aspects, the method may include recordingelectrophysiological activity before, during, and/or after the neuralblock to determine the effects thereof on the bladder, and/or assessingif the change in electrophysiological activity caused by the neuralblock is desirable, if so, delivering sufficient therapy to the regionso as to form a substantially irreversible neural block.

In aspects, the therapy may be delivered in the form of a radiofrequency current, cryoablation, an ultrasonic wave, a microwave, achemical agent, or thermal energy.

In aspects, one or more one or more of the steps of the method may beperformed using a surgical tool in accordance with the presentdisclosure.

According to aspects there is provided, an implantable device formonitoring electrophysiological activity within a bladder, including ahousing including a microcircuit configured to acquire and communicatesignals and a power supply or energy harvesting element to provide powerto the microcircuit, the housing configured and dimensioned forplacement within and attachment to a wall of the bladder, and one ormore sensing tips electrically coupled with the microcircuit configuredto interface with the wall of the bladder, the sensing tips configuredto convey one or more electrophysiological signals associated with theactivity to the microcircuit.

In aspects, the electrophysiological signals may be related to one ormore of water concentration, tissue tone, evoked potential, remotelystimulated nervous activity, a pressure stimulated nervous response, anelectrically stimulated movement, sympathetic nervous activity, anelectromyographic signal [EMG], a mechanomyographic signal [MMG], alocal field potential, an electroacoustic event, vasodialation, bladderwall stiffness, muscle sympathetic nerve activity [MSNA], centralsympathetic drive, nerve traffic, combinations thereof, or the like.

In aspects, the implantable device may include a pressure sensorelectrically coupled with the microcircuit configured to measure a fillpressure within the bladder.

In aspects, one or more sensing tips may include a microelectrodeconfigured to interface with the associated wall of the bladder, themicroelectrode having an area of less than 5000 μm², less than 1000 μm²,less than 250 μm², or less than 100 μm², and/or one or more stimulatingelectrodes, electrically coupled with the housing, arranged so as tointerface with the wall of the bladder, the stimulating electrodesconfigured to provide a stimulating and/or ablating current to the wallof the bladder.

In aspects, the implantable device may include a plurality ofstimulating electrodes, each stimulating electrode electrically coupledwith the microcircuit configured to coordinate stimulating and/orablating currents between two or more of the stimulating electrodes viathe wall of the bladder.

In aspects, one or more of the sensing tips may be configured so as tomonitor the effect of the stimulating and/or ablating current(s) on thewall of the bladder.

In aspects, the implantable device may be configured to deliver atherapeutic substance in accordance with the present disclosure to thewall of the bladder. In aspects, one or more of the sensing tips may beconfigured to monitor the effect of the therapeutic substance on thebladder. In aspects, the therapeutic substance is selected from achemical, a drug substance, a neuromodulating substance, a neuroblockingsubstance, an acid, a base, a denervating agent, or a combinationthereof. In aspects, the therapeutic substance is a selected from aneurotoxin, a botulinum toxin, a tetrodotoxin, a tetraethylammonium, achlorotoxin, a curare, a conotoxin, a bungarotoxin, arsenic, ammonia,ethanol, hexane, nitric oxide, glutamate, resiniferatoxin, alchohol,phenol, capaicin, an anesthetic, lidocaine, tetanus toxin, quaternaryammonium salts, a pachycurare, a leptocurare, acetylcholine,aminosteroids, or a combination thereof. In aspects, the therapeuticsubstance may be included within a restraining matrix in accordance withthe present disclosure. In aspects, the restraining matrix is at leastpartially biodegradable.

According to aspects there is provided, use of one or more devices,systems, and/or methods in accordance with the present disclosure totreat overactive bladder (OAB), interstitial cystitis (IC), bladdercancer, ureteral stent pain/voiding dysfunction, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-b show aspects of a surgical tool placed within a urinarybladder in accordance with the present disclosure.

FIG. 2 shows aspects of a surgical tool in accordance with the presentdisclosure.

FIG. 3 shows a non-limiting example of a balloon wall in accordance withthe present disclosure.

FIGS. 4a-d show aspects of substrates in accordance with the presentdisclosure.

FIGS. 5a-b show aspects of a surgical tool with flexible wire elementsin accordance with the present disclosure.

FIG. 6 shows aspects of a surgical tool with a deployable substrate inaccordance with the present disclosure.

FIG. 7a-d show aspects of a surgical tool with deployable mesh inaccordance with the present disclosure.

FIG. 8 shows aspects of a surgical tool with a counter electrode inaccordance with the present disclosure.

FIG. 9 shows aspects of a surgical tool with one or more remotemonitoring sites in accordance with the present disclosure.

FIG. 10 shows a urinary bladder with non-limiting examples of treatmentpatterns thereupon.

FIG. 11 shows a graphical display of the relationship between localneurological activity and bladder fill volume before, during, and aftertreatment with a device in accordance with the present disclosure.

FIGS. 12a-d show aspects of methods for using a surgical tool inaccordance with the present disclosure.

FIGS. 13a-c show aspects of a surgical tool in accordance with thepresent disclosure.

FIG. 14 shows aspects of a device for assessing local physiologicalresponse and/or treating a local tissue site in accordance with thepresent disclosure.

FIG. 15 shows a graphical relationship between a probe and physiologicalmeasurements performed with a device in accordance with the presentdisclosure.

FIGS. 16a-c show aspects of tip electrode configurations for a surgicaltool in accordance with the present disclosure.

FIG. 17 shows aspects of a microfilament array based surgical tool inaccordance with the present disclosure, placed within a urinary bladder.

FIGS. 18a-e show aspects of microfilament tips in accordance with thepresent disclosure.

FIG. 19 shows aspects of a microfilament array based surgical tool inaccordance with the present disclosure.

FIGS. 20a-c show aspects of a microfilament array based surgical tool inaccordance with the present disclosure.

FIGS. 21a-c show aspects of measurements made over a surface with amicrofilament array based surgical tool in accordance with the presentdisclosure.

FIG. 22 shows aspects of a balloon based surgical tool in accordancewith the present disclosure.

FIG. 23 shows assessment zones associated with a balloon based device inaccordance with the present disclosure.

FIG. 24 shows aspects of a microfilament based surgical tool in physicalcontact with a tissue site in accordance with the present disclosure.

FIGS. 25a-c show aspects of an implantable device in accordance with thepresent disclosure and a schematic of an implantable device attachedwithin the inner wall of a urinary bladder.

FIG. 26 shows aspects of a system in accordance with the presentdisclosure.

FIGS. 27a-c show aspects of a system for mapping and/or overlayingphysiological response onto a surgical display during a procedure inaccordance with the present disclosure.

FIG. 28 shows aspects of a system for performing a surgical procedure inaccordance with the present disclosure.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are describedhereinbelow with reference to the accompanying drawings; however, thedisclosed embodiments are merely examples of the disclosure and may beembodied in various forms. Well-known functions or constructions are notdescribed in detail to avoid obscuring the present disclosure inunnecessary detail. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the presentdisclosure in virtually any appropriately detailed structure. Likereference numerals may refer to similar or identical elements throughoutthe description of the figures.

A controlled denervation system in accordance with the presentdisclosure may include the capability to sense one or more physiologicalparameters at one or more points around a surgical site. In aspects, thedenervation system may include the capability to stimulate and/or ablatetissues at one or more of the same sites, and/or include the capabilityto stimulate, deliver a neuromodulating substance, and/or ablate tissuesat one or more of the sites and/or an alternative site in the vicinityof a surgical site. In aspects, a nerve ablation system in accordancewith the present disclosure may be configured so as to access aninternal cavity wall (e.g., the wall of a bladder, a vagina, a uterus,an intestine, a urethra, a colon, a rectum, etc.) in a body. One or moreaspects of the non-limiting examples disclosed herein may be directedtowards such configurations (e.g., so as to controllably ablate bladdernerves and/or tissues sites along the bladder wall during a surgicalprocedure).

A controlled nerve ablation system and/or neuromodulation system inaccordance with the present disclosure may include one or more sensingtips (e.g., as located on a micro-tip, a wire, an electrode in a matrix,on a flexible balloon, a clamp, a hook-like structure, a net-likestructure, etc.). One or more sensing tips may include a pressuresensor, a tonal sensor, a temperature sensor, an electrode (e.g., tointeract with a local tissue site, provide a stimulus thereto, measure apotential therefrom, monitor current to/from the tissues, to measure abioimpedance, measure an evoked potential, neural activity, anelectromyographic signal [EMG], an electrocardiographic signal [ECG], amechanomyographic signal [MMG], a local field potential, etc.), anacoustic sensor, an oxygen saturation sensor, or the like.

The sensing tips may be configured to elucidate a range of keyphysiological aspects during a procedure. The following descriptionoutlines some non-limiting approaches in this respect. Such sensing tipsmay be integrated into one or more microfingers, micro-tips, clampfaces, tool surfaces, flexible circuits, stretchable substrates, balloonwalls, or the like, each in accordance with the present disclosure.

Bioimpedance between one or more sensing tips may be used to determinethe degree of contact between one or more of the sensing tips and theanatomical site, as well as potentially the bias force between thesensing tips and the anatomical site. Additionally, alternatively, or incombination, bioimpedance measurements between one or more sensing tipsmay be useful in determining when adequate contact has been made as wellas how much treatment should be applied to an anatomical site during asurgical procedure (e.g., during thermal ablation, RF ablation,ultrasonic ablation, chemical denervation, etc.). Furthermore,additionally, alternatively, or in combination bioimpedance between oneor more sensing tips may be used to determine the status of tissuepositioned there between. In one non-limiting example, the bioimpedancespectrum between two or more sensing tips may be used to map the localtissue impedance. Such information may be useful to elucidate where suchtissue has been completely treated (e.g., ablated, abraded, etc.), wheretissue has yet to be treated, etc.

In aspects, bioimpedance measurement between one or more sensing tips, asensing tip and a separate electrode, etc. may be used to determine astate of isolation between one or more of the sensing tips and a localfluid (i.e., to determine a state of isolation between a sensing tip andfluid within a lumen, to determine the state of contact between one ormore sensing tips and an organ wall, to determine the filled state of anorgan, etc.).

In aspects, one or more sensing tips in accordance with the presentdisclosure may be configured to obtain mechanomyographic informationduring a procedure as determined by slight changes in an associatedstrain measurement, tip vibration, and/or contact force measurement(e.g., via direct force measurement between the tip and the localanatomy, and/or via changes in the deformation of the microfinger asmeasured by an associated micro strain gage attached thereupon).Mechanomyographic information may be related to local nervous activityeither naturally occurring or in response to a stimulus (e.g.,optionally applied by one or more sensory tips, locally, remotely,during and/or via a local RF pulse, etc.). In aspects, a sensing tip mayinclude a piezoresistive strain gauge, a piezoelectric microtransducer,an interfacial pressure sensing membrane, or the like to detectmechanomyographic signals. In one non-limiting example, the sensing tipmay be coated with a micro or nano coating of a piezoresistive and orpiezoelectric material (e.g., a piezoelectric polymer, an electret, anano-particulate filled elastomer, a conjugated polymer, etc.). Inaspects, the mechanomyographic tip may be configured so as to measureone or more aspect of the tissue compliance of the local tissues (e.g.,so as to identify calcified material, cancerous tissues, etc.).

In aspects, a sensing tip, an associated microfinger, and/or anassociated electrical interconnect (e.g., a wire interconnect, a printedinterconnect, a patterned interconnect, etc.), may include one or morepiezoresistive material. A change in impedance of the piezoresistivematerial during a procedure may be used to determine one or moremyographic physiological responses (e.g., movement, neurologicallyinduced activity, etc.) associated with one or more aspects of anassociated procedure.

In aspects, the mechanomyographic tip may be configured so as to measureone or more aspect of the tissue compliance of the local tissues (e.g.,so as to identify calcified material, cancerous tissues, tissues withincreased connective tissues, local changes in wall thickness, etc.).

In aspects, one or more sensing tips in accordance with the presentdisclosure may be configured to monitor an electrophysiological signal.Such electrophysiological monitoring at and/or between one or moresensing tips, may be used to map nervous response, electromyographicresponse (EMG), evoked potential, local field potential, extracellularfield potentials, etc. along and/or within the wall of the localanatomical site (e.g., the wall of a lumen, along the wall of an organ,along a bladder wall, within an intestinal wall, near a ganglion, in thevicinity of a nerve plexus, etc.). Such information may be advantageousfor selecting tissues on which to perform a surgical procedure (e.g., anablation procedure, a neuromodulation procedure, signal interruption,chemical delivery, an abrasive procedure, a biopsy, etc.), to followand/or map a nerve along the length of the surgical site, to determinethe state of a surgical procedure, etc. In aspects, one or more sensingtips may be configured to monitor a local electromyographic (EMG) signalbefore, during and/or after a surgical procedure as a means formonitoring local nervous activity (i.e., muscular activity associatedwith nerve traffic, etc.). In such aspects, the EMG signals may be usedas feedback for monitoring the extent of a denervation orneuromodulation procedure.

In aspects, one or more sensing tips in accordance with the presentdisclosure may be configured to monitor the tone of a tissue within abody. Monitoring the tone (e.g., mechanical properties, wall stiffness,elastic spectral response, mechanical impedance, physiologicalproperties, etc.) of the adjacent tissues may be determined by combiningstrain and/or force measurement of the sensing tips while applyingmovement (optionally cyclical or oscillatory movement) to one or moresensor tips. Such sensing tips may be excited locally (e.g., such as bya local piezoelectric transducer, a capacitive transducer, anelectrochemical transducer, a smart material, etc.) or globally (e.g.,such as by transverse oscillations, axial oscillations, generaloscillations of the surgical tool tip, the clamp, the hook, the loop,etc.).

In aspects, one or more of the sensing tips may be interfacedasymmetrically with the associated tissues (i.e., with a bent tip, amicro finger, a wire-like finger configured substantially parallel tothe tissue surface, oriented at an acute angle thereto, etc.). Byasymmetrically is meant such that the sensing tip approaches theassociated tissue surface at an angle other than perpendicular thereto.To describe the use of such a tip to monitor local tissue tone and/orfor providing a local excitation (e.g., an electrical excitation,mechanical excitation, etc.) may be applied with relatively smallamplitude so as not to generate substantial relative movement betweenthe tissue and the tip during the excitation process (e.g., such thatthe transverse contact forces remain below the slip conditions betweenthe tip and the tissue, such that they move together during excitation).By relatively small is meant an excitation that is sufficiently small inamplitude such that the sensing tip may not appreciably slide along thetissue surface. In aspects, one or more sensory tips, in a structureattached thereto, and/or a system in accordance with the presentdisclosure may include a vibratory exciter may be configured to generatethe excitation.

In aspects, such a tone monitor may be combined with interfacial contactsensing, electrophysiological measurement, and/or sensor tip strainmeasurement in order to generate a wealth of local tissue relatedphysiological information before, during, and/or after a surgicalprocedure. In one non-limiting example, the local tissues may stiffenduring an ablation procedure. By monitoring local tissue tone, astiffness level may be used to characterize when a suitable degree ofablation has been applied so as to irreversibly damage the tissues.Monitoring of a local tissue tone, perhaps at a monitoring sitesignificantly removed from the surgical site such that the surgicalprocedure does not directly affect tissues in the vicinity of themonitoring site (i.e., does not directly cut, heat, ablate, abrade, thetissues, etc.) may also be advantageous for determining an effect of thesurgical procedure on one or more physiological parameters of a tissue(e.g., an organ wall stiffness, change in nerve activity, change inlocal blood perfusion, etc.) adjacent to the monitoring site.

In aspects, such tone measurement may be useful in determining the localstiffness of tissues (and/or overall wall stiffness of an adjacentvessel, organ, etc.) in contact with a sensing tip array (e.g., so as todetermine the type of tissue adjacent to one or more sensing tips,locate plaque, locate a cancerous tumor, etc.). Tone measurement mayfurther be used to characterize the type of tissue with which the tip isinterfacing (e.g., muscle, nervous tissue, fat, plaque, canceroustissue, etc.). In aspects, such information, possibly in combinationwith bioimpedance data, electrophysiological monitoring, or the like,may be used to determine how much RF energy to apply locally during anRF ablation procedure.

In aspects of a method for RF ablating tissue in accordance with thepresent disclosure, the local tissue tone may be measured before,during, between individual RF pulses, and/or after a train of RF pulses.As the local tissue tone changes during application of the RF pulses,the tonal changes may be used to determine the extent of the therapy. Asthe RF ablation process is applied to the adjacent tissues (perhaps viaone or more sensing tips), the tonal measurements (as determined by oneor more sensing tips, perhaps the same tip through which the RF signalmay be applied) may be monitored as the tonal measurements may not besignificantly affected by the local RF currents.

In aspects, electrophysiological stimulation and/or sensing from one ormore sensing tips in a sensing tip array, or a system in accordance withthe present disclosure may be used to interface with, monitor and/orstimulate nervous function within a local anatomical structure (e.g., alumen wall, a vessel wall, along a nerve, an organ wall, a duct, etc.).Such information may be used to hunt for target tissues (e.g., nerves),select tissues for a surgical procedure, to determine the degree ofprogression of a surgical procedure (e.g., a degree of ablation duringRF surgery, etc.), determine interconnection of a neural target with anadjacent organ and/or physiological function thereof, or the like.

In aspects, an array of sensing tips may be configured to apply adirectional stimulation and/or multi-site sensing so as to selectivelytreat/monitor only nerves that are configured to send signals in thepreferred direction (e.g., to selectively target primarily efferentnerve bundles, afferent nerve bundles, etc.). Such a configuration maybe advantageous for treating a neurological disorder with minimal impactto the surrounding anatomy and physiological function of the associatedorgans.

In aspects, one or more sensing tips in accordance with the presentdisclosure may include the capability to apply/receive an RF currentto/from the surrounding tissue. The RF current may be provided locallybetween two of more sensing tips, or alternatively between one or moresensing tips and a macroelectrode placed elsewhere on the body (e.g., ona large skin patch over the surgical site, as selected from multiplepatches placed over the body, etc.). In aspects where current may berestricted to being applied between sensing tips, the path for currentflow may be well controlled, yet may be highly localized. Alternatively,in an example where RF current is passed between one or more sensingtips and one or more macroelectrodes, the direction of current flow maybe more challenging to control, but may be used to access tissues moreremote from the sensing tips (i.e., farther into the adjacent tissues,deeper into an organ, farther from a lumen wall, etc.).

In aspects, network impedance measurements between one or more sensingtips and one or more macroelectrodes (e.g., as attached to the body ofthe patient), may be monitored prior to and/or during application of anRF ablation current. Each sensing tip and/or macroelectrode may includean impedance control circuit that may be adjustable such that theoverall current flow through the network formed from all the elements iscontrolled there through. Such a configuration may be advantageous tomore precisely control the local ablation process, thus targeting thelocal tissues with more accuracy, precision, spatial discrimination, andconfidence than less controlled approaches.

In aspects, a plurality of sensing tips may be engaged with the flow ofRF current during an ablation process. In aspects, the local impedanceof each microfinger and/or sensing tip may be monitored and/orcontrolled so as to better optimize the current delivered thereto.Additionally, alternatively, or in combination, the local current flowthrough each sensing tip may be monitored so as to determine the path ofthe RF current flow, to ensure no leakage currents are detected, etc.Such information may be used to more precisely control the delivery ofRF currents to the local anatomy during an ablation procedure.

Additionally, alternatively, or in combination, before, during and/orafter the RF current is applied to the surrounding tissues, one or moresensing tips may monitor a physiological parameter (e.g., waterconcentration, tone, blood oxygen saturation of local tissues, evokedpotential, stimulation/sensing of nervous activity, local fieldpotential, extracellular activity, EMG, temperature, etc.) to determinethe extent of completion of the intended surgical procedure.

In aspects, one or more sensing tips may include an optical microsensor(e.g., a micropackage including a light source and/or a CMOSphotosensor) and/or a fiber optic element. During a surgical procedure,the optical microsensor may be positioned against or near to the localtissues for analysis before, during and/or after an ablation procedure.

In aspects, an optically configured sensing tip (or group of tips) maybe configured to locally assess blood perfusion and/or blood oxygenationin the tissues adjacent thereto. The system may be configured toautomatically adjust and/or halt the surgical procedure based uponchanges in this signal. Alternatively, additionally, or in combination,the system may alert a user (e.g., a surgeon, an attendant, etc.) to achange in this signal before, during, and/or after a surgical procedure.Such a configuration may be useful for assessing local tissue healthbefore, during, and/or after a surgical procedure, the extent of asurgical procedure, etc.

In aspects, one or more optically configured sensing tips may beconfigured so as to be biased towards the tissues of a lumen, a vessel,or the like in the vicinity of the surgical site. The optical sensingtips may include one or more light sources (e.g., light emitting diodes,fiber optic tips, etc.) configured to deliver narrow, multiband, and/orwideband light to the adjacent tissues. In aspects, one or more of theoptical sensing tips may include one or more photodetectors (e.g., aphotodetector, a phototransistor, a fiber optic tip, etc.) to receiveand/or analyze the light reflected from the adjacent tissues. Thereceived light may be related to that emitted by one or more of thelight sources, or may be received from an ambient light source, perhapslocated to the exterior of the organ (e.g., external to the organ,remote from the adjacent tissues, from within the bladder cavity,vaginal cavity, rectum, etc.), or the exterior of the subject's body.

The sources may be configured to emit light at predetermined wavelengthssuch that different absorption characteristics of the adjacent tissues,perhaps dependent on the wavelengths, may be observed during thesurgical procedure. The photodetectors may be configured to receive atleast a portion of this light, so as to assess the absorptioncharacteristics with the system (perhaps via a pre-amplification systemin accordance with the present disclosure, in an attached electronicsunit, etc.). The photodetected signals may be used to determine anoximetry value or a signal related thereto.

In aspects, the optically configured sensing tips may be biased towardsa site on the exterior of an adjacent vessel wall before, during, and/orafter the surgical procedure. Alternatively or in combination, theoptically configured sensing tips may be substantially stationary withrespect to the vessel wall (such as via being attached to a collar ofknown size, attached to a structure of known width, as part of astructure that is expanded to a known radius, etc.). In aspects, themagnitude of the bias may be controlled by sensors and actuators bothaccordance with the present disclosure. Changes in the optical signalsdetected by the photodetectors (perhaps due to changing bias force)before, during and/or after a surgical procedure may be related tochanges in the bias force with which they are held against the vesselwall. Such a configuration may be advantageous for determining a changein sympathetic tone and/or vasodialation before, during and/or after asurgical procedure.

In aspects, the optically configured sensing tips may be coupled withone or more strain and/or interfacial force measurement methods, perhapsto give a more precise reading of the bias force between the sensingtip(s) and the adjacent tissues, to compensate for movement relatedartifacts, or the like.

In aspects, one or more of the optical sources may be selected such thatthe penetration of the light into the adjacent tissues may becontrolled. In one non-limiting example, a substantially blue wavelengthand a substantially red wavelength may be emitted into the tissues. Theblue wavelength may provide information relating to the deformation andabsorption near to the surface of the tissues, while the red wavelengthmay penetrate more deeply into the adjacent tissues, providing a signalthat changes in response to deformation of tissues farther from thecontact site(s) between the tip(s) and the tissue. The photodetectors orequivalent optical detection pathway may include filters, polarizedwindows, or the like to separately assess the different spectra duringan analysis. Comparison between photodetected signals in the bluespectrum with those obtained from the red spectrum may be used todetermine tone and/or elastic modulus of the tissues of the vessel inthe vicinity of the sensing tip(s). Such a configuration may beadvantageous for assessing sympathetic tone (i.e., via muscular tensionmeasurement), and/or vasodialation, organ wall stiffness, and/or localtissue stiffness before, during and/or after a surgical procedure.Changes in such properties may be indicative of the degree of completionof the surgical procedure.

In aspects, an externally placed (e.g., onto the body of the subject)light source (e.g., infrared, near infrared, visible, etc.) may bedirected into the body towards the surgical site. The light source mayoptionally be modulated to provide a more easily detected signal withinthe subject. One or more sensing tips equipped with optical microsensorsmay sense light emitted from the light source. The mapping of receivedlight may be used to locate and/or localize one or more anatomicalfeatures such as nerves near to one or more of the optical microsensorequipped sensing tips.

In aspects, one or more externally placed light sources and/or radiationbased imaging source may be used to help locate the anatomical sites ofinterest during the procedure. An external energy source may include anarrow band light source, a broad band light source, radiologicalsource, ultrasonic source, light sources spaced apart from each other,and/or combinations thereof, or the like. The energy sources may bemodulated so as to be more easily detectable by sensors located on, in,or near to the anatomy of interest. In one non-limiting example, aplurality of light sources may be aimed at the surgical site fromdistinct vantage points within the body (i.e., as accessed via anendoscopic procedure, etc.) or externally to the body (i.e., aspositioned at locations on the body).

In aspects, an endoscopic camera may be placed near to the anatomy,lumen wall, and/or surgical site of interest during a procedure toobserve both the anatomy, as well as placement of the surgical tools inthe vicinity of the anatomy. In one non-limiting example, the endoscopiccamera and/or light source may provide a suitable macroelectrode for RFablation processes performed during the surgical procedure.

In aspects, one or more sensing tips may be equipped with acorresponding micro-light source (e.g., an oLED, an LED, etc.). Themicro-light source may be used to direct light into the adjacenttissues. One or more sensing tips equipped with optical microsensors maybe configured to detect light emitted from the micro-light source asback scattered by and/or transmitted through the adjacent tissues. Suchinformation may be used to detect anatomical features (e.g., nerves,tumors, etc.) in the adjacent tissues, monitor local fluids (i.e., watercontent, blood flow, etc.), interact with tissue visualizing materials,for inspecting tissues within the organ wall, etc.

Such optical configurations may be advantageous for mapping the localtissues before, during and/or after a surgical procedure. They may alsobe advantageous for implementation into a nerve detection system (e.g.,perhaps as input to a nerve hunting algorithm, etc.). In aspects, such asystem may be embodied by an optical coherence tomographic (OCT)configuration.

In aspects, the system may include a micro balloon catheter forplacement into an organ (e.g., a bladder, a vagina, a uterus, a rectum,a colon, an intestine, etc.) or within tissues adjacent thereto, etc.The micro balloon catheter may be coated with a thin layer of anindicator molecule. The indicator molecule may be tagged to attach tothe target tissue of interest and/or tagged so as to change chromaticproperties when bound to the target tissue (e.g., nervous tissue, etc.).The molecules may be delivered to the desired tissues during a ballooncatheterization procedure. During such a procedure, the micro ballooncatheter may be placed into the organ of interest and inflated so as tokiss the walls of the organ. While in contact with the organ walls, theindicator molecules may attach and migrate/diffuse into the localtissues. Such a procedure may be performed as a first surgical step oras combined with other aspects in accordance with the presentdisclosure. In aspects, the balloon may also be configured to deliver atherapeutic agent (i.e., a neuroblocking agent, ethyl alcohol, botox,etc.) to the anatomy of interest.

In a method in accordance with the present disclosure, one or moresensing tips may be inserted into a tissue adjacent to a target organ(i.e., a bladder, vagina, colon, uterus, etc.), and/or a lumen with awall within a body and biased towards the wall of the lumen or thetarget organ, and one or more electrophysiological signals obtainedtherefrom. The electrophysiological signals may be analyzed to locateone or more target tissues for a surgical procedure (i.e., one or moresympathetic nerves, parasympathetic nerves, etc.). A bolus oftherapeutic agent (e.g., a neural ablative chemical, a neuroblockingsubstance, a neuromodulating substance, etc.), an RF current, a thermalenergy source, and/or the like may be delivered to the identifiedtissues so as to perform the surgical procedure thereupon. In aspects,one or more post-procedural electrophysiological signals may be analyzedto determine the extent of the surgical procedure.

In aspects, the therapeutic agent may be provided via a micro ballooncatheter in accordance with the present disclosure. In aspects, themicro balloon catheter may include one or more sensory tips (e.g., inthe form of functional elements attached to the balloon, attached to asuperstructure surrounding the balloon, etc.) in accordance with thepresent disclosure.

In aspects, the bioimpedance and/or electrophysiological signals betweenone or more sensing tips in the array and one or more sensing tips inthe array, an external electrode, a reference electrode, or the like maybe used to determine changes in the structure of the adjacent tissuesduring an ablation procedure. Such information may be useful indetermining the extent of the ablation procedure, char accumulation,etc.

In aspects, bioimpedance measurements may be correlated with nervedamage data, perhaps obtained during prior surgeries, development of theprocedure, and/or obtained during specific testing procedures, such thatchanges in local bioimpedance data may be used during a surgicalprocedure to determine the extent of the ablation procedure. Such aconfiguration may be advantageous in the case that the surgicalprocedure itself overwhelms the local electrophysiological activity tothe extent that neurological monitoring may be hindered for a prolongedperiod of time after the procedure has been completed.

In aspects, one or more sensing tips may be configured to monitor localelectrical fields during an ablation procedure in accordance with thepresent disclosure in order to better determine the current flow paththrough the adjacent anatomy, perhaps connected to a warning system toindicate to an operator when the ablation field is insufficient forachieving the intended goal. Such a configuration may be advantageousfor avoiding unnecessary damage to the tissues during a misfired ormisdirected ablation session.

In aspects, a system in accordance with the present disclosure mayinclude a micro balloon catheter including one or more sensory tips(e.g., in the form of functional elements attached to the balloon,attached to a superstructure surrounding the balloon, etc.). The microballoon catheter may be configured so as to bias the sensory tipsagainst the adjacent organ walls, thus providing a reliable interfacefrom which selective ablation and detection processes may be performed.Such a micro balloon catheter may be advantageous for single placementtype surgical procedures in accordance with the present disclosure.

In aspects including a plurality of sensing tips (e.g., as placed onto amicro balloon catheter, surgical tools, a clamp, a hook, a loop, amicrofinger array, a microtool set, a flexible cage assembly, a balloonwall, a flexible cage assembly, etc.) the sensing tips may beinterconnected with each other, with signal processing circuitry, alocal microcircuit, and the like and/or combinations thereof. In orderto substantially reduce the number of signal wires that must be sent tothe surgical site during the procedure, the networked array of sensingtips may be multiplexed together with a locally placed microcircuit(e.g., an application specific integrated circuit,distributed/interconnected circuit elements, a collection of flexiblesemiconducting circuit elements, etc.). The microcircuit may beconfigured to communicate such signals with an extracorporeal system(e.g., a computer, a control system, an RF ablation controller, a dataacquisition system, etc.). The microcircuit may be configured tocommunicate with the extracorporeal system via analog and/or digitalmeans and/or methods. In one non-limiting example, the communication maybe of primarily digital means such that the microcircuit may exchangedata pertaining to any sensing tip in the array, as well as switch data,control data, RF pulse routing, etc.

In aspects, the networked array of sensing tips may be interconnectedwith distributed electronic elements and flexible electricalinterconnects (e.g., as applied to a balloon wall, as provided bystructural wires, microfingers, wire mesh elements, etc.). In aspects,one or more of the sensing tips, microfingers, or the like may beincluded upon a flexible or stretchable electronic substrate, theelectronic substrate configured to interface the sensing tips with theanatomy as well as to electrically connect one or more sensing tips, orthe like with a controller, a control system, an operator, a graphicaluser interface, a display, or the like.

A controlled nerve ablation system in accordance with the presentdisclosure may include one or more microfingers.

To this effect, a microfinger array microsurgical tool is disclosedherein. Any element in the microfinger array may include a sensing tipin accordance with the present disclosure to interact with the localanatomy during a surgical procedure.

The microfinger array may be advantageous for accessing very smallanatomical sites within a body, for highly localized interaction with atissue site, etc.

In aspects, a microfinger array may be arranged in a surgical tool inaccordance with the present disclosure such that one or more of themicrofingers may substantially independently interface with the adjacenttissues. Thus if an array of microfingers is placed against a rough orotherwise uncontrolled surface, each microfinger may be able to contact,maintain a controlled bias force against, substantially embed anassociated sensing tip into, and/or substantially maintain contact withthe surface during use, even if the microfinger array is dragged alongthe surface as part of a procedure, during movement of the surface, etc.Such independently adjustable microfingers may be advantageous so as tomaintain a known interfacial pressure, especially while monitoring,stimulating and/or ablating the tissue with the microfingers. Suchindependently adjustable microfingers may be advantageous tosubstantially embed an associated tip (i.e., an associated sensory tip)into an adjacent tissue during a procedure.

By microfinger is meant a substantially curved finger like member (i.e.,with curvature at one or more points along the length thereof, withmulti-axial curvature, etc.). Such microfingers may generally have acharacteristic width (although may be of any cross sectional makeup).The microfingers may generally have characteristic widths on the orderof approximately 1 mm, 0.5 mm, 0.1 mm, 0.05 mm, 0.01 mm, or the like. Inone non-limiting example, one or more microfingers may include a Nitinolstructure (e.g., a wire, a ribbon, etc.) with characteristic width ofapproximately 100 um, approximately 50 um, approximately 25 um, etc.

In aspects, one or more regions of a microfinger in accordance with thepresent disclosure may be selectively coated with an isolation layer(e.g., an oxide layer, a dielectric coating, a polymer layer, alubricious layer, etc.). In aspects, such an isolation layer may beselectively applied to regions of the microfingers (i.e., so as tocreate isolated regions and sensitive regions thereof).

In aspects, the microfingers may be configured so as to deploy and/orbias against one or more adjacent tissue structures during a procedureand may be used to contact ably sweep the local anatomy, for purposes ofsensing, stimulating, and/or ablating during a surgical procedure. Inaspects, one or more microfinger dimensions and structure may bedesigned so as to provide substantially uniform and predictable biasforces on the adjacent tissues over a wide range of movements anddimensional variation.

In aspects, an array of microfingers in accordance with the presentdisclosure may be configured so as to sufficiently collapse down into adelivery catheter while expanding outwards upon deployment so as to forma controllably biased contact within an anatomical structure (e.g., anorgan, etc.) or for convenient delivery to a surgical site (e.g., withintissues surrounding a bladder, a uterus, a vagina, a rectum, etc.).

In aspects, one or more microfingers in accordance with the presentdisclosure may be configured into the shape of a wire basket, amesh-like structure, or the like. In aspects, one or more regions ofsuch microfingers may be patterned with an isolation layer, so as todirect signals over the microfingers, towards associated sensing tips,to provide communication between associated sensing tips and controlelectronics, to control one or more mechanical properties thereof, orthe like.

Such a configuration may be advantageous for accessing anatomical sitesof interest with minimal damage, while also maintaining consistentcontact forces at a surgical site during a procedure, substantiallyembedding one or more sensory tips into an organ wall, tissue structureof interest, substantially isolating one or more sensing tips from anadjacent fluid, or the like.

In aspects, a microfinger array in accordance with the presentdisclosure may include a plurality of fingers, one or more such fingersconfigured to interface with the surrounding tissues and biased radiallyoutwards from a deployment site (e.g., a guide wire, a catheter, etc.).In aspects, the microfinger array may be deployed via longitudinalretraction of a restraining shell (i.e., a restraining layer in thecatheter), via application of heat or current (i.e., in the case of ashape memory microfinger, etc.), via projection of the microfinger arrayout of a delivery catheter (i.e., by advancing the microfinger arraybeyond the tip of the delivery catheter, etc.).

In aspects, one or more microfingers may include a spring-like wireelement (e.g., Nitinol, spring steel, etc.) and/or may include compositestructures including a spring-like element to provide a bias force so asto push the tip and/or one or more regions of the microfinger towardsthe wall of an organ into which it is placed (i.e., towards a surface,etc.).

In aspects, a microfinger may include a Nitinol structure, optionallyconfigured for passage of current flow, to and from the surroundingtissues, and/or communication of electrophysiological informationbetween an associated sensing tip and a connected microcircuit. Inaspects, the Nitinol structure may be configured such that, when an RFpulse is applied there through towards the surrounding tissues, theNitinol structure may retreat from the tissues after a predeterminedamount of energy has passed there through, upon reaching a predeterminedtemperature, or the like. Thus the Nitinol structure may provide aninherently controlled method for applying a quantum of RF energy to thesurrounding tissues. Such a configuration may be adapted for usesimultaneously, additionally, alternatively and/or in combination withone or more of the other aspects described in this disclosure.

In aspects, each finger in the array may move somewhat independently ofthe others such that all fingers may maintain contact with an organwall, a target tissue, or the like, during a procedure.

Such a configuration may be advantageous for maintaining robust contactwith the interior and/or exterior walls of a muscular organ (i.e., abladder, a uterus, a vagina, etc.), while performing a procedure (i.e.,scanning a surface with one or more microfingers, dragging a microfingeralong a surface, monitoring a tissue site, ablating a tissue site, etc.)or during periods of relative movement (i.e., in the presence of organmovement, perhaps due to physiological processes, stresses related tobiorhythms, breathing, blood pressure variation, contractions, etc.).

In aspects, the microfingers may be formed slightly off axis to adelivery catheter, such that relative axial movement of an overlyingsheath may be used to retract the microfingers into the sheath orconversely to deploy them towards the anatomical site. Additionally,alternatively, or in combination, off axis arrangements may provide thecapability to sweep the microfingers circumferentially along theanatomical site via applying torsion to catheter to which they areattached.

Such a configuration may be advantageous for simultaneously mapping andselectively ablating an anatomical site during a surgical procedure.

Furthermore, such a configuration may be advantageous for working uponan anatomical site, while maintaining flow of fluid there through (i.e.,as opposed to an occlusive tool, which may block flow during expansionthereof).

In aspects, one or more microfingers may be provided with highlyminiaturized and flexible structure so as to more easily access highlyrestricted anatomical sites within the body, and/or so as to reachsurgical sites of interest with minimal damage to the surroundingtissues.

In aspects, one or more microfingers may include one or more sensingtips in accordance with the present disclosure for capturing informationfrom the local surgical site. Some non-limiting examples of sensingoptions include temperature sensors, electrodes, strain gauges, contactforce sensors, combinations thereof, and the like. For purposes ofdiscussion, a sensing tip may also be referred to as a microsensor.

The sensing tips may be configured to elucidate a range of keyinformation during a procedure. Some aspects are discussed in moredetail below.

Bioimpedance between one or more microfinger tips may be used todetermine the degree of contact between the finger tips and theanatomical site, the water content of tissues between the microfingertips, the state of tissues between the microfinger tips, as well aspotentially the bias force between the finger tips and the anatomicalsite. Such information may be useful in determining when adequatecontact and to gauge how much current should be applied to an anatomicalsite during an ablation procedure.

Mechanomyographic information may be obtained from fingertips during aprocedure as determined by slight changes in an associated strainmeasurement and/or contact force measurement (e.g., via direct forcemeasurement between the tip and the local anatomy, and/or via changes inthe deformation of the microfinger as measured by an associated microstrain gage attached thereupon).

Evoked potential monitoring at or between one or more finger tips, maybe used to map nervous response, electromyographic response,extracellular potentials, local field potentials, evoked potential, etc.along the wall of the local anatomy (e.g., vessel wall, organ wall,etc.) or within tissues associated with the surgical site, etc. Suchinformation may be advantageous for selecting tissues on which toperform a surgical procedure (e.g., an ablation procedure, a biopsy, astimulation procedure, a chemical delivery event, etc.).

The tone of the adjacent tissues may be determined by combining strainand/or force measurement of the microfingers while applying anexcitation to one or more microfingers (e.g., optionally clockwisetorsion to advance the microfingers and small counterclockwise torsionto measure the tone of adjacent tissues, a vibratory exciter incombination with contact and/or microfinger strain measurement, etc.).

Such tone measurement may be useful in determining the local stiffnessof tissues in contact with the microfinger array (e.g., so as todetermine the type of tissue adjacent to one or more microfingers, tomonitor local stiffness changes in response to a surgical procedure, tolocate plaque, to locate a cancerous tumor, etc.).

Stimulation and sensing from one or more microfingers in the microfingerarray may be used to elicit nervous function of local anatomy. Suchinformation may be used to select tissues for a surgical procedure, todetermine the degree of progression of a surgical procedure (e.g., adegree of ablation during RF surgery, effect of a chemical substancedelivered into the surrounding tissues, etc.). Directional stimulationand sensing may be used to selectively treat only nerves that areconfigured to send signals in the preferred direction (i.e., viacombination of stimulation and/or sensing from a plurality of sensingtips, sensing sites, etc.).

In aspects, one or more microfingers may include the capability toapply/receive an RF current to/from the surrounding tissue.

Such RF currents may be applied between one microfinger in the array andan (optionally) distant counter electrode, between two or moremicrofingers in the array, to a extracorporeal patch on the body, etc.

In aspects pertaining to multiple microfinger RF current passage, thelocal impedance of each microfinger may be altered so as to control thecurrent delivered thereto.

In aspects pertaining to multiple microfinger RF current passage, thelocal current flow through each microfinger may be monitored so as todetermine the path of the RF current flow, to ensure no leakage currentsare detected, etc. Such information may be used to more preciselycontrol the delivery of RF currents to the local anatomy during anablation procedure.

In aspects, prior to, during, and/or after the RF current is applied tothe surrounding tissues, one or more microfingers may be configured tomonitor a physiological parameter (e.g., water concentration, tone,blood oxygen saturation of local tissues, evoked potential, one or morelocal field potentials, stimulation/sensing of nervous activity, EMG,temperature, etc.) to determine the extent of completion of the intendedsurgical procedure.

In aspects, the bioimpedance between one or more microfingers in thearray may be used to determine changes in the structure of the adjacenttissues during an ablation procedure. Such information may be useful indetermining the extent of the ablation procedure, char accumulation,changes in tissue impedance, etc.

In aspects, bioimpedance measurements may be correlated with nervedamage data, perhaps obtained during prior surgeries or obtained duringspecific testing procedures, such that changes in local bioimpedancedata may be used during a surgical procedure to determine the extent ofthe procedure. Such a configuration may be advantageous in the case thatthe surgical procedure itself overwhelms the local electrophysiologicalactivity to the extent that neurological monitoring may be hindered fora prolonged period of time after the procedure has been completed.

In aspects, one or more microfingers may be configured to monitor localelectrical fields during an ablation procedure in order to betterdetermine the current flow path through the adjacent anatomy, perhapsconnected to a warning system to indicate to an operator when theablation field is insufficient for achieving the intended goal, toassist with the direction of energy towards the intended surgical site,to conserve energy, etc. Such a configuration may be advantageous foravoiding unnecessary damage to the tissues during a misfired ablationsession.

In aspects, the system and/or microfingers may include a coolantdelivery system (e.g., a saline delivery system) in order to cool themicrofingers during and/or after an ablation procedure. Such coolantdelivery may be advantageous for minimizing char and excessive damageassociated with an ablation procedure. In aspects, such coolant deliverymay be part of a cryogenic surgical procedure (i.e., cryoablation), orthe like.

In aspects, one or more microfingers may include an exposed electrodearea (i.e., as part of an electrode based sensing tip) that only touchesthe walls of the adjacent anatomy. Such a configuration may beadvantageous for minimizing current flow into the adjacent fluids withinthe vessel (i.e., to substantially isolate the electrode from fluidswithin an organ, etc.), to better control RF current flow in thevicinity of the electrodes, minimize conductivity between the exposedarea and the surrounding fluid, so as to substantially embed the exposedelectrode area in to the wall of the adjacent anatomy, etc.

In aspects, one or more microfingers may include one or more activematerial elements. Control signals delivered to the active materialelement may help to bias the microfingers towards the intended surgicalsite, actively control the contact forces between finger tips and thesurgical sites, etc. Some non-limiting examples of active materials thatmay be suitable for application to one or more microfingers includeshape memory materials (e.g., shape memory alloys, polymers, combinationthereof), electroactive polymers (e.g., conjugated polymers, dielectricelastomers, piezoelectric polymers, electrets, liquid crystals, graftelastomers, hydrogel actuators, etc.), piezoceramics (e.g., amorphouspiezoceramics, single crystals, composites, etc.). In addition theactive material may be used as a vibratory exciter and/or mechanicalprobe, for use in monitoring the tone of the adjacent tissues (seeabove), alternatively, in addition or in combination, to causevibratory/ultrasonic ablation and/or local heating to the tissues. Insuch aspects, the active material may be included along the lengthand/or over a region of the microfinger (i.e., so as to influence theshape of the microfinger during contraction or expansion of the activematerial).

In aspects, one or more sensing tips may include a conjugated polymerelectrode to interface with the adjacent tissues. Some non-limitingexamples of suitable conjugated polymers include polyaniline,polypyrrole, polyacetylene, poly(3,4-ethylenedioxythiophene), and thelike.

In aspects, one or more microfingers may include an electrical shieldsuch that the microfinger tips are effectively shielded from othercurrents flowing through an associated catheter, the body, etc. during aprocedure.

In aspects, one or more elements of a microfinger based catheter mayinclude a bidirection switching network, micro amplifier array, asensory front end, combinations thereof, or the like in order to amplifysensed signals as close as possible to the anatomical interface, toswitch the function of a microfinger tip between sensory, stimulatory,and/or ablative functions, perform combinations thereof, or the like. Inaspects, the circuitry may be included in the delivery wire within thecatheter of the system. In such aspects, the circuitry may be coupled toone or more microfingers and/or sensing tips each in accordance with thepresent disclosure, and a secondary signal acquisition circuit, adigital communication block, a controller, an RF signal generator,combinations thereof, and the like.

In aspects, a bidirectional switching network may be used to enablebifunctional stimulation/sense capabilities in one or more microfingers,etc. The switching network may be included in a local amplifier array,as a flexible circuit, or silicon die interconnected to or placed uponone or more microfingers, etc. Alternatively, additionally, or incombination, an extracorporeal circuit element may be coupled to theswitching network and/or microfingers, sensing tips, etc. and to acontroller included within a surgical system including a microfingerarray in accordance with the present disclosure.

In aspects, a micro amplifier array may be used to preamplify thesignals obtained from one or more sensory aspects of the microfingers,so as to improve the noise signature, etc. during use. Themicroamplifier may be coupled to the catheter, embedded into thecatheter, embedded into one or more microfingers, etc.

In aspects, one or more microfingers in accordance with the presentdisclosure may be provided such that they are sufficiently flexible soas to buckle, or change orientation during back travel, so as to preventpuncture of the local anatomy. A configuration as outlined in thisnon-limiting example may be advantageous for providing contact with thelocal anatomy without significant risk of damaging the adjacent anatomy(e.g., puncturing an organ wall, etc.) which may be a concern withstiffer structures. Such microfingers may include a characteristic widthof less than 200 um, less than 100 um, less than 50 um, less than 25 um,less than 10 um.

In aspects, one or more microfingers in accordance with the presentdisclosure may include a substantially hyper elastic material (e.g.,formed from a memory alloy material, a superelastic material, a springsteel, etc.) so as to effectively deploy from a very small deploymenttube/catheter and expand outward to accommodate a large range of vesseldiameters or changes in shape during deployment. Such a configurationmay be advantageous in so far as a small number of unit sizes may besuitable for treating a wide range of anatomical structures. Inaddition, the designed curvature and form of a microfinger may besubstantially chosen so as to further enable a wide deployable range ofmovement.

A surgical tool including a plurality of microfinger arrays (i.e.,clusters of microfingers, fans of microfingers, etc.) may be employed soas to determine physiological response more remotely from an intendedsurgical site than may be available within a single array. Aspects ofthe disclosed concepts may be employed along the same lines by extendinginteractions between microfingers within an array, to inter-arrayinteractions. In aspects, a surgical tool including a plurality ofclustered microfinger arrays may be advantageous to analyze one or moreanatomical sites simultaneously from a plurality of sites(macroscopically separated sites). In aspects, two microfinger arraysmay be arranged along a catheter based surgical tool, so as to interfacewith the walls of a lumen, at two or more longitudinally separateddistances, between a surgical site of interest and a (somewhat) remotelocation, or the like. Physiological sensing from multiple microfingersmay be advantageous for determining the extent of neurological trafficbetween the plurality of sites, determine the direction of traffic,determine if traffic from one direction or the other is blocked (i.e.,after a surgical procedure, after RF current application, after adenervation procedure, etc.). Such configurations and methods fordetermining the state of a plurality of anatomical sites is furtherdisclosed throughout the text and appended figures of this disclosure.

In aspects, a system in accordance with the present disclosure may beused to monitor physiological activity associated with a surgical siteprior to, during and/or after a surgical procedure is applied thereto.Some suitable examples of surgical procedures include an RF ablation,Argon plasma coagulation, laser ablation, water jet ablation, ultrasonicablation, cryoablation, microwave ablation, abrasion, biopsy, deliveryof a substance (e.g., a chemical, a drug substance, a neuromodulatingsubstance, a neuroblocking substance, a neurotoxin, an acid, a base, adenervating agent, etc.), combinations thereof, and the like. The localphysiological activity (e.g., nervous activity, blood perfusion, tonalchanges, muscular sympathetic nerve activity, etc.) may be monitoredwith one more sensors (sensing tips, microfingers, etc.), perhaps incombination with one or more physical sensors (i.e., temperaturesensors, pressure sensors, etc.), and/or associated stimulators each inaccordance with the present disclosure. Additionally, alternatively, orin combination, a technique for assessing one or more physiologicalproperties and/or states of an associated surgical site may be employed.Such techniques include assessing values and/or trends in bioimpedance,blood pressure, tissue oxygenation, tissue carbon dioxide levels, localtemperatures, combinations thereof, changes thereof, and the like.

In aspects, the system may include a substrate onto which the sensingtips may be placed. Such a substrate may be formed from a balloon wall,a mesh, an interwoven ribbon array, a cloth, a clamp face, a hook face,etc. In aspects, the substrate may include stretchable and/or flexibleelectronic materials.

Electrical interconnects may be formed from carbon nanotubes (e.g.,SWNTs, MWNTs, etc.), nanowires, metallic wires, composites, conductiveinks, patterned versions thereof, combinations thereof, and the like.

In aspects, a portion, or all of the substrate and/or an associatedsubstrate carrier film may be formed from polyurethane, a silicone, ageneral elastomer, silk fibroin materials, combinations thereof, or thelike. Inclusion of microporous or fibrous substrates may be advantageousto allow the substrate or substrate carrier film to adhere to theadjacent tissues via capillary effects (i.e., tendencies to wick fluidfrom adjacent tissues into the substrate). In aspects, the thickness offilms formed from the material may be less than 50 um thick, less than30 um thick, less than 20 um, less than 10 um, less than 4 um, less than1 um. Composites of somewhat stiffer materials (such as polyimide, PET,PEN, etc.) and somewhat softer materials (e.g., silicones,polyurethanes, thermoplastic elastomers, etc.) maybe used to compromisebetween overall structural stiffness and conformal capabilities of thesubstrate.

In aspects, patterned overcoats and/or composite layers may also be usedto expose electrode materials and/or sensing tips to the surroundingtissues in the vicinity of measurement regions, etc.

In aspects, a substrate in accordance with the present disclosure may beformed from a silk material (e.g., Bombyx mori cocoons). The materialmay be processed to remove sericin (which may cause undesirableimmunological response) using methods known in the art. The resultingmaterial can be solvent cast into shapes and crystallized to formself-supporting structures.

In aspects, adaptive temperature estimation may be used to bettercontrol the RF ablation process. Such techniques may be supported by useof a surgical tool in accordance with the present disclosure, includingone or more sensing tips configured with temperature and/or bioimpedancemonitoring aspects. Modeling of changes in local bioimpedance may berelated to local temperature changes during the ablation process. Suchmeasurements as well as local thermoconductive properties, tissuethermoconduction, etc. may also influence the rates at which a localablation process may take place (i.e., as related to a thermal ablationprocess).

In aspects, a system in accordance with the present disclosure mayinclude one or more microsensors for monitoring nervous activity and/orrelated physiological activity before, during, and/or after the surgicalprocedure. Some non-limiting examples of suitable monitoring techniquesinclude electromyography (EMG), muscle sympathetic nerve activity(MSNA), mechanomyography (MMG), phonomyography (PMG), extracellularpotentials, local field potentials, combinations thereof; and the like.Mechanomyography (MMG) measures the force created by local musclecontractions caused by associated neural activity. Phonomyography (PMG)measures low frequency sounds associated with movement generated byassociated neural activity. Traditionally, techniques such as MMG andPMG have been employed on externally accessible nervous and musculartissues. One advantage of such techniques is that they may not be aseasily affected by local electrical noise as EMG and the effects of thenervous activity may be generally sensed farther from the associatednerve than with electromyographic techniques.

Alternatively, additionally or in combination the ascribed sensingtechniques may be combined with stimulation from local sources inaccordance with the present disclosure. Such stimulation and sensing maybe advantageous in determining functionality of local nerves without theneed to listen to complex biologically generated nervous activity.Furthermore, combined stimulation and sensing may be advantageous fordetermining functionality of a local nerve in real-time during adenervation and/or ablation procedure (e.g., the successive stimulationand sensing may be used to determine the degree of neurological blockand/or neuromuscular block there between). In aspects, suchfunctionality as well as directionality of the nerve signal propagation(e.g., efferent, afferent, etc.) may be more easily determined throughuse of combined local stimulation and sensing.

In aspects, one or more patterns of nerve stimulation may be used todetermine the function of the local nerve structures as well as one ormore aspects of neurological block and/or neuromuscular block that maybe caused by the surgical procedure (e.g., ablation), anesthesia,heating, chemical delivery, a related condition, etc.

In aspects, a single stimulation may be applied to elicit maximalresponse from the associated nerve at frequencies of less than 10 Hz,less than 1 Hz, less than 0.1 Hz. The downstream response as measured byany of the described techniques will depend on the frequency with whichthe stimuli are applied. In aspects, in order to allow for completerecovery of the nerve between stimulations, a frequency of less than orequal to 0.1 Hz may be advantageous.

During RF ablation of an associated nervous structure, the evokedelectrical and/or muscular responses may be dramatically affected. Suchchanges in the response may be useful in determining the state of thedenervation procedure. Thus they may be advantageous to determine theexact degree of RF energy that must be applied to a given structure inorder to cause sufficient denervation as desired by a surgicalprocedure. Such an approach may be advantageous to limit damage tosurrounding tissues caused by the denervation procedure, to ensuresuitable denervation has been achieved, to determine which nerves areaffected by the procedure, to control the extent of a denervationprocedure, etc.

Another technique for stimulation and sensing of the nervous responseincludes applying a rapid succession of pulses followed by a period ofinactivity. Pulse trains may be used to gradually force a nerve into ablocked state. The rate at which a nerve enters a blocked state andlater recovers therefrom may be a suitable indicator of the overallhealth and functionality of the nerve (i.e., a suitable metric fordetermining how a procedure has affected that nerve).

In aspects, the sensing of the nervous response may not need to be localto a surgical site, but rather downstream (in the sense of the flow ofan associated nervous signal) from the site. Such sensing of the nervousresponse may be advantageous for determining the progression of aparticular form of communication past a surgical site (i.e., afferent,efferent traffic, etc.).

In aspects, various mapping techniques may be applied to the surgicalsite, before, optionally during, and/or after a surgical procedure. Somemapping techniques as used in cardiac interventions include pacemapping, activation mapping, entrainment mapping, and substrate mapping.It may be feasible to adapt such techniques for use in the intendedapplication and/or a system in accordance with the present disclosure.In general, these techniques may complement each other in localizingwhere amongst a surgical site to target the ablation procedure.

Additionally, or in combination to the aspects described herein, thesurgical system may be configured to monitor one or more physiologicalparameters at one or more locations in the body remote from the surgicalsite. Some non-limiting examples of what may be monitored include waterconcentration, tone, blood oxygen saturation of local tissues, evokedpotential, stimulation/sensing of nervous activity, electromyography,temperature, blood pressure, vasodialation, vessel wall stiffness,muscle sympathetic nerve activity (MSNA), central sympathetic drive(e.g., bursts per minute, bursts per heartbeat, etc.), tissue tone,blood flow (e.g., through an artery, through a renal artery), a bloodflow differential signal (e.g., a significantly abnormal and or suddenchange in blood flow within a structure of the body, a vessel, an organ,etc.), blood perfusion (e.g., to an organ, an eye, etc.), a bloodanalyte level (e.g., a hormone concentration, norepinephrine,catecholamine, renine, angiotensin II, an ion concentration, a waterlevel, an oxygen level, etc.), nerve traffic (e.g., post ganglionicnerve traffic in the peroneal nerve, celiac ganglion, superiormesenteric ganglion, aorticorenal ganglion, renal ganglion, and/orrelated nervous system structures), combinations thereof, and the like.

In aspects, a surgical system in accordance with the present disclosuremay include one or more elements to monitor physiological activityand/or analyte levels (e.g., a hormone level), in and/or near to one ormore portions of a gland, an endocrine gland (e.g., an adrenal gland, anadrenal medulla, etc.), at a site within the central nervous system,etc.

In aspects, a multi tool surgical system may be employed, each catheterin accordance with the present disclosure. In one non-limiting example,one or more first tools may be used to probe and/or ablate tissues at afirst surgical site (e.g., within an organ, a bladder, an intestine, avagina, a uterus, a first nerve structure, a nerve plexus, etc.) whileone or more second tools may be configured to monitor one or morephysiological parameters elsewhere in the body (e.g., in an artery, avein, further along the first nerve structure, in an organ, at a lymphnode, at a ganglion, etc.), perhaps to determine the effect of thesurgical procedure there upon. In one non-limiting example, the toolsmay be inserted into the same or closely positioned entry points intothe body (e.g., a body opening, a urethra, a vagina, a rectum, one ormore transcutaneous entry points, etc.). Such a configuration may beadvantageous for providing a minimally invasive surgical tool to performthe surgical procedure (e.g., a sympathectomy, a renal sympathectomy, aneuromodulation procedure, etc.).

Some further aspects relating to systems and methods for adjusting(temporarily and/or permanently) nerve function, while substantiallyminimizing collateral damage to adjacent structures via devices, tools,catheters, and methods are now discussed. References made to ablationmay be considered to refer to a general surgical procedure (to cut,heat, cool, excise, chemical delivery, etc.) on a tissue.

Herein the general reference to electrodes, sensors, etc. may equallypertain to sensing tips in accordance with the present disclosure.

A surgical tool in accordance with the present disclosure may include anarray of electrodes. The array of electrodes may be used to interfaceintimately with the local tissues, so as to select ablation sites,validate ablation success, sense local neural activity, stimulate andsense, etc.

Electrodes in the array may be used to stimulate, sense and/or ablatelocal tissues and/or monitor nervous activity before, during and/orafter a related surgical procedure or ablation process.

In aspects, a tool in accordance with the present disclosure may includea switch array in accordance with the present disclosure, optionallywith amplifiers such that one or more electrodes could be configured forstimulation, ablation, and/or sensing.

The tool may include electronics to monitor bioimpedance between one ormore electrodes (i.e., so as to determine when the tool is adequatelybiased against the intended anatomical structure, etc.).

In aspects, the tool may include electronics for automaticallyterminating an ablation signal when a change in the sensed nervousactivity is detected. In one non-limiting example, a pulsatilestimulation is applied to one side of the ablation zone, perhaps duringthe ablation process and/or between ablation pulses (and/or perhapsintermixed with the ablation pulses). Another electrode may be placed tothe opposing side of the ablation zone so as to monitor nervous responsebefore, during and/or after the ablation procedure.

In aspects, one or more electrodes in an array may be preconfigured soas to provide a particular function, sense, stimulate and/or ablatelocal tissues.

One or more electrodes in the array may be a monopolar electrode or partof a bipolar pair. In one example, two or more electrodes may bearranged into pairs, multi-polar interconnects, etc.

In aspects, the electrodes may be configured so as to protrude from aface of the tool (e.g., via emboss, plating, filament, mattedmorphology, application of microfiber structures thereupon, etc.). Inaspects, one or more of the microelectrodes may be embossed so as tobetter bias the interfacing aspects of the tool towards the tissueduring a procedure. This may be advantageous to ensure that eachelectrode applies adequate pressure to the adjacent tissues and/or toimprove the chances of tissue contact with a plurality of the electrodes

A method for determining the functionality, directionality, location ofand/or the extent of nerve function degradation before, during and/orafter a surgical procedure may include stimulating a one or more nerveslocated at a proximal and/or distal location on an organ (e.g., abladder, an intestine, a uterus, a gland, etc.) in a body; monitoring anevoked response at a location distal and/or proximal to the location ofthe stimulation; evaluating the signal quality, spectral content, etc.related to the evoked response and/or changes in the evoked responseduring and/or after the surgical procedure. One or more steps of themethod may be performed with one or more surgical tools each inaccordance with the present disclosure.

In aspects, one or more of the methods in accordance with the presentdisclosure may include stimulating the stimulation location (e.g., anerve, a tissue site, etc.) with one or more pulse trains, the pulsetrains including one or more pulses with a predetermined spectralcontent (e.g., pulses centered around 10 Hz, 50 Hz, 100 Hz, 500 Hz,etc.) at one or more locations proximal and/or distal to the surgicalsite.

The pulse train may be applied locally to the stimulation location(e.g., nervous structure, tissue site, etc.), with an amplitude ofgenerally 1.5× the voltage required to obtain a maximal amplitudecompound action potential (CAP), with pulse duration of generallybetween 0.05 and 0.5 ms and interval of between 2 ms (for 500 Hzspacing) to 100 ms (for 10 Hz spacing). The pulse train may include oneor several such pulses, perhaps even spaced with alternative timing overthe application of the pulse (so as to better scan through a frequencyrange of interest). The corresponding nervous response may be monitoredat another location on the vessel or in the body. Such response may bemonitored with a gain of generally 500 to 5000 and generally over afrequency band of 0.1 Hz to 10 kHz. This configuration may be used toevaluate the overall health and/or capability of the nervous structureconnecting the stimulating location and the monitoring location.

During a surgical procedure, early indication of functional alterationto the nerve structure may be determined by monitoring for a change inthe properties of the sensed signal (e.g., a change in latency,amplitude, conduction velocity, spectral content, etc.). In aspects, anablation pulse may be applied to the nerve between the stimulatory andmonitoring locations. A change in the properties of the sensed signal(e.g., a decrease in high frequency content therefrom, a change inlatency, change in amplitude, etc.) may be an early indicator that thepulse is being applied properly to the nervous structure there between.In addition, additional pulses may be applied and the response monitoredin order to observe the nerve response through to a sufficient state offunctional alteration, such as during an ablation procedure.

Monitoring may continue during a follow up period immediately after thesurgical procedure, and/or during a longer term period (e.g., hours,days, weeks, etc.). Such follow up may be used to determine and/orprognosticate on the longevity of the surgical intervention. Such followup may be performed with an implantable device in accordance with thepresent disclosure.

In aspects, one or more of the techniques disclosed herein may be usedto identify the particular neurons of interest, or to ensure that thecorrect neurons are being treated surgically (as well as to ensure thatthe extent of the treatment is acceptable). Such identification mayinvolve monitoring a level of neurological activity on the sensednerve(s) to determine if the levels are outside of the norm (i.e., ascompared with other sites in the body, an activity metric for thepatient population or a subset thereof, etc.).

A method for generating a follow up schedule following a surgicalprocedure may involve monitoring the neurological activity of the sitefor a period of time (e.g., hours, days, weeks, etc.) after the surgicalprocedure; trending the neurological activity to create a metricrelating to changes therein over the period of time; and predictingrecurrence data (e.g., probability of recurrence, a timeframe ofrecurrence, etc.) therefrom; and generating a follow up scheduledependent upon the recurrence data.

A method for searching for a nerve of interest on the wall of a bladdermay include applying a point pressure on the wall of the bladder whilemonitoring distal and/or proximal nervous activity (e.g., monitoring,and/or stimulation and sensing on either side of the point pressureprobe, along an associated nerve plexus, along a sacral nerve, etc.).Changes in the observed signals may be indicative of pressure inducedneural block and/or triggering of a sensory nerve due to the appliedpoint pressure (i.e., thus identifying the location of the neuralanatomy under investigation).

The method may include poking one or more regions of the organ wall(e.g., bladder wall) with a smooth protruding probe, to increasepressure at the interface between the probe and the tissues. The probemay be combined with an ablation electrode (thus providing colocation ofthe pressure application and the ablation zone). Multiple probes may beused together to deliver ablation along the length of a nerve or nervebundle, over an extended region of the organ wall, etc. In aspectsincluding multiple probes, one or more probes may be relatively placedonto the surface so as to optimize an ablation current passed therebetween.

Relating to nerve compression syndrome, acute nerve compression studieshave shown some loss of nerve function through application of acutetransverse pressure above 40 mmHg, and loss of all nerve function atpressure application above 50 mmHg. Other studies have shown functionalblock under transverse compression when a pressure of 30 mmHg less thandiastolic pressure is applied and 45 mmHg less than the mean arterialblood pressure is applied to the nerve. Thus one or more components ofthe system (e.g., a probe, a microfinger, a sensory tip, an electrodeelement, a point pressure applicator, etc.) may provide pressurevariation above and/or below these ranges during a procedure in order toassess nerve function, location, etc. as described herein.

In aspects, a point pressure applicator may be configured to operativelyprovide an oscillating pressure to the test site, to synchronizepulsatile pressure application with an array of probes, etc. so as tobetter orient a pair or array of probes for an ablation procedure.

In aspects, a hook-like tool in accordance with the present disclosure(e.g., with one or more sensing tips thereupon, configured as anelectrode element, etc.) may be used to make consistent and controlledcontact with the target anatomy (so as to access large surface of theanatomy with a simple tool). A soft hook-like structure with tissueinterfaces (electrode arrays, sensing tips, etc.) fashioned towards theinner surface could be used to delicately contact the key anatomy duringa surgical procedure. The hook may include a quick release (e.g., amechanical quick release, an electroactive material quick release,etc.), or a biodegradable structures, etc. for simple removal fromand/or positional correction along the anatomy (e.g., an organ wall,etc.) during, and/or at the conclusion of a surgical procedure.

A sensing tip in accordance with the present disclosure may be attachedto the hook to enable sensing and/or interfacing with the adjacenttissues during an associated surgical procedure.

In aspects, a method for searching for a nerve of interest on the wallof a target organ may include applying a point pressure on the wall ofthe vessel while monitoring distal and/or proximal nervous activity(e.g., monitoring, and/or stimulation and sensing on either side of thepoint pressure probe). Changes in the observed signals may be indicativeof pressure induced neural block due to the applied point pressure(i.e., thus identifying the location of the neural anatomy in question).

In aspects, the method may include clamping the vessel with a flat,smooth backing plate (e.g., a flat soft surface, etc.) and a protrudingprobe on the adjacent wall, to increase pressure at the interfacebetween the probe and the tissues. The probe may be combined with anablation electrode (thus providing colocation of the pressureapplication and the ablation zone). Multiple probes may be used togetherto deliver ablation along the length of a nerve or nerve bundle. In thecase of multiple probes, the probes may be relatively placed onto thesurface so as to optimize an ablation current passed there between.

Relating to nerve compression syndrome, acute nerve compression studieshave shown some loss of nerve function through application of acutetransverse pressure above 40 mmHg, and loss of all nerve function atpressure application above 50 mmHg. Other studies have shown functionalblock under transverse compression when a pressure of 30 mmHg less thandiastolic pressure is applied and 45 mmHg less than the mean arterialblood pressure is applied to the nerve. Thus one or more components ofthe system (e.g., a sensing tip, a balloon face, an electrode element, apoint pressure applicator, etc.) may provide pressure variation aboveand/or below these ranges in order to assess nerve function, location,etc. as described herein for the application of interest.

The point pressure applicator may be configured to operatively providean oscillating pressure to the test site, to synchronize pulsatilepressure application with an array of probes, etc. so as to betterorient a pair or array of probes for an ablation procedure.

In aspects, the biasing force between one or more surgical elements(e.g., a balloon, a microfinger, a point pressure applicator, etc.) andthe adjacent tissues may be controlled by various means includingfeedback via bioimpedance measurements, interfacial pressure sensors,micro-pulse oximetry based measurements, through flow and/or localperfusion measurements, via optically equipped sensing tips,combinations thereof, and the like. It may be desirable to control theapplication of force for various reasons such as causing signalinhibition via mechanical compression (nerve compression); for imposinga temporary nerve block during an associated procedure; to mask theunderlying nervous activity during surgical site selection; to controlone or more contact pressures and/or impedance for performing anassociated ablation and/or monitoring procedure.

In aspects, a surgical tool in accordance with the present disclosuremay include a means for applying a vacuum at sites in and around theelectrodes. Such vacuum attachment may allow for very intimate yetgentle contact between the adjacent tissue surface and the electrodesduring a procedure.

In aspects, a soft flexible structure in accordance with the presentdisclosure may be used in conjunction with a surface enhancement and/orwicking function (a hydrophilic material, a porous material, etc.) so asto draw fluid out from the target tissue surface and use the resultingcapillary forces and surface tension to form a tight, intimate contactbetween the tool and the tissue suitable for neurovascular monitoring.This may be an option for long term placement (e.g., placing of animplantable component during a procedure for follow up, etc.). Silkstructures included into the flexible structure may be suitable forproviding this functionality, optionally with a first layer that candissolve quickly and a second layer that may dissolve over the course ofhours, days, weeks, etc.

In aspects, the flexible structure may include a medicament (e.g., aneural blocking agent, an anesthetic, lidocaine, epinephrine, a steroid,a corticosteroid, an opioid, alcohol, phenol, etc.). In aspects, theflexible structure may include a medicament releasing structure (i.e., ahydrogel structure) into which the medicament is bound, and may bereleased into the surrounding tissues over the course of minutes, hours,days, weeks, etc. In aspects, the hydrogel may be formed from a radicalbased crosslinking chemistry, a click crosslinking chemistry, etc.

In aspects, a surgical tool in accordance with the present disclosuremay be configured to deliver a bolus of medicament into the tissues ofinterest. In aspects, the bolus may be housed in a hydrogel prepolymer,the surgical tool including means for polymerizing the hydrogelprepolymer in place after release to form a slow release structure, fromwhich the medicament may leach into the surrounding tissues over aprolonged period of time (i.e., hours, days, weeks, months, etc.). Inaspects, the hydrogel may include biodegradable chains, configured so asto allow for breakdown of the hydrogel over time, after being placedwithin the body of a subject.

In aspects, the structure may include a thin degradable supportstructure. The support structure may be degradable so as to quicklydissolve in the presence of liquid (saline) such that it may be placedbeside the organ wall and wetted, so as to cause the remaining structureto flop down, and/or otherwise contact the organ wall.

In aspects, the system may include one or more sensing tips (e.g., tonalmeasuring, optically equipped, electrodes, etc.) positioned to theinterfacing side, i.e., the side that may interface with the adjacentanatomy.

Such soft configurations may be useful to establish a reliable, yetgentle contact to a vessel surface, intimately contouring to the surfaceof the vessel without applying excessive pressure thereto. Intimate yetsoft contact may be advantageous for reading sensitive neurologicalsignals without interfering mechanically with signal transmissionthereof.

A surgical tool in accordance with the present disclosure may includeone or more whiskers extending from a tool surface so as to reliablycontact an adjacent tissue structure during a surgical procedure. Thewhiskers may include sensing tips such as electrodes, and the like.Additionally, alternatively, or in combination, a sensing tip inaccordance with the present disclosure may include a whisker forinterfacing with the adjacent tissues during a procedure.

In aspects, whisker penetration into an adjacent nerve bundle may beused to achieve more intimate contact thereto, as well as to betterisolate electrodes from other macroscopic signal interference, etc.

In aspects, whiskers may be formed from microfibers, nanofibers,microneedles, nanoneedles, etc. In one aspect, one or more whiskers maybe formed from a carbon structure, e.g., a carbon fiber, a carbonnanotube, etc. In aspects, the whiskers may be insulated along a portionof their length, with an electrically exposed region at the tip thereupon.

In aspects, one or more of the whiskers may be substantially hollow,configured so as to store a medicament in accordance with the presentdisclosure, to provide a means for delivery of a medicament inaccordance with the present disclosure, or the like.

In aspects, a boundary method for monitoring a surgical site during asurgical procedure may be employed. During this approach a plurality ofsensor tips may be arranged in contact around a perimeter of a surgicalregion on a tissue surface, whereby the electrophysiological signalsmeasured at locations along the surface may be used to determine thestate of the tissues within the boundary. For purposes of discussion,the boundary may be effectively the distal and proximal ends of thevessel or the ends of the surgical area, when applied to a tubular organof interest.

In aspects, a visual detection approach may be used in combination with,or in addition to any of the endoscopic approaches in accordance withthe present disclosure. In aspects, visual assessment may be used to atleast partially guide the surgical procedure. The feedback may be in theform of a visible, a near infrared, infrared spectroscopic, or similarcamera system, used in conjunction with the surgical tools, so as tobetter visualize the vessel structure, identification of target anatomy(e.g., a nerve, nerve bundle, etc.) on the target organ (e.g., abladder, a uterus, etc.), perhaps placement of tools onto the targetanatomy, etc.

In aspects, a backlit vessel lighting system may be used to assist withvisualizing the anatomy, locating target anatomy, etc.

In aspects, a system in accordance with the present disclosure mayinclude a feature enhancing medium, to highlight targeted tissue species(e.g., highlight nerve tissues, etc.). The medium may include molecularbinding species to selectively bind with surface receptors on theintended target tissue, perhaps changing one or more visual (chromatic)properties in the process and/or including a visual marking moiety. Somenon-limiting examples of suitable molecular binding species are peptidesand aptamers. Suitable peptides and aptamers may be selected for targettissue (e.g., nerve tissue, fat, etc.) and may be selected as known inthe art.

Inclusion of molecular binding species that have been selected for thetarget cells may be advantageous to assist with anatomical visualizationduring a surgical procedure. The molecular binding species may beprovided suspended in a delivery vehicle, such that it may beconveniently delivered to the target tissues during a procedure. Thedelivery vehicle may be a gel material, a 1 part curing gel, elastomer,etc. that may be conveniently delivered to the target tissues. A fullycurable vehicle may be advantageous for providing a simplified methodfor completely removing the medium from the body after the surgicalprocedure and/or targeting process has been completed.

Molecular binding species may include a visual marking moiety that isconfigured to improve visibility thereof. Thus the molecular bindingspecies may bind to the target tissue sites (e.g., nerve tissue, etc.),and may be highlighted by the visual marking moiety for visualizationwith an appropriate visualization system. Some non-limiting examples ofvisual marking moieties include: 5-carboxyfluorescein;fluorescein-5-isothiocyanate; 6-carboxyfluorescein;tetramethylrhodamine-6-isothiocyanate; 5-carboxytetramethylrhodamine;5-carboxy rhodol derivatives; tetramethyl and tetraethyl rhodamine;diphenyldimethyl and diphenyldiethyl rhodamine; dinaphthyl rhodamine;rhodamine 101 sulfonyl chloride; Cy3, Cy3B, Cy3.5, Cy5, Cy5.5, Cy7,indocyanine green, IR800CW or combinations thereof.

This visualization approach may be advantageous to identify the keytissues for surgical procedures (such as renal sympathectomy). Byproviding the material in a form suitable for surgical delivery andcomplete removal post operatively, the resulting system may be safercompared to approaches that require systemic application of thematerial.

A system in accordance with the present disclosure may include animplantable tool, configured to be left in the body following thesurgical procedure for purposes of follow up.

In aspects, the implantable tool may include one or more sensing tips(i.e., MMG sensors, electrodes, etc.) to interface with the adjacenttissues.

In aspects, the implantable tool may include a draw cord, configured tomechanically connect the tool to the exterior of the body. Uponcompletion of the monitoring period, the draw cord may be used towithdraw the implantable tool from the body. Thus the implantable toolmay provide follow up monitoring for days, weeks, to months aftersurgery, but may still be removed from the patient in an out-patientsetting.

The implantable tool may include communication circuitry to communicatemonitored signals or signals created therefrom to a monitor outside ofthe body. Such a system may be used to monitor nerve function (e.g.,electrophysiological signals, nerve activity, EMG, etc.) to determine ifthe undesirable signal or neurological behavior is returning or notafter the surgical procedure. Thus the implantable tool may providefollow up monitoring for days, weeks, to months after surgery, but canstill be removed from the patient in an out-patient setting.

The implantable tool may be used to monitor the site after surgery, todetermine if the functional changes will last indefinitely, for a shortperiod of time, etc. Such a tool may be useful for scheduling follow up,prognosticating on patient outcomes, etc.

In aspects, the surgical system may include other functionalityincluding: angiographic die delivery, saline delivery, temperaturemonitoring, intra and extra corporeal coordination between devices,through wall imaging, through wall current flow, saline provision forlocal tissue cooling, radiopaque markers for identification byassociated imaging systems, optical coherence tomographic (OCT)capabilities, and the like.

In aspects, a system in accordance with the present disclosure may beconfigured to map various electrophysiological aspects of an organ wall.In aspects, the system may be configured to identify abnormal nerveactivity, thus providing a means for selective sympathectomy of nerves(sensory nerves, afferent nerves, efferent nerves, etc.) in the bladderto treat a disease state (e.g., to treat overactive bladder).

The system may include one or more means for monitoring neurologicalfeedback, locally and/or distant to the surgical site, for feedback ofadequate denervation in accordance with the present disclosure.

In aspects, the system may include means for monitoring urge (i.e., asensation of a need to urinate) based feedback, monitoring signalactivity as a function of bladder fullness, and the like before, during,and/or after an associated procedure. Such monitoring may be influencedby one or more features of the system (e.g., as controlled by fluidexchange with the bladder during a procedure, as controlled by inflationof a balloon in the bladder during a procedure, etc.).

In aspects, the system may include means for capturing and/or monitoringpatient feedback relating to sensation, pain, fullness, etc. before,during, and/or after a surgical procedure and/or associated urge basedfeedback study (e.g., a urodynamic study, a balloon inflation procedure,etc.). Such means may include video monitoring of a subject during aprocedure, monitoring one or more nerves, sacral nerves, EMG of musclesin the vicinity of the bladder (i.e., detrusor muscle contraction,spasm, etc.), audibly requesting feedback from the subject, combinationsthereof, or the like during a procedure. Such feedback may be used as asurrogate or as supplemental evidence for determining thecompleteness/effectiveness of an associated procedure.

In aspects, a method in accordance with the present disclosure may beused to test for and/or diagnose a disease state in a subject (e.g.,diagnose overactive bladder). The method includes placement of a portionof a system, a device, and/or a surgical tool in accordance with thepresent disclosure into the bladder of a subject, biasing one or moreaspects of the device against the wall of the bladder, obtainingfeedback from the aspect of the device (e.g., sensing tip, microfinger,probe, etc.) to assess local nervous activity in accordance with thepresent disclosure, optionally changing the bias and monitoring one ormore aspects of the neurological response thereto so as to establish therelationship there between, and comparing the feedback and/or responseto a population statistic (e.g., average response, median response),and/or population based model so as to determine if the behavior isnormal. Such information may directly give information pertaining to thediagnosis of the disease state. Furthermore, the system may includeaspects to treat the disease state directly after diagnosis during thesame interventional procedure in accordance with the present disclosure.

Additionally, alternatively, or in combination, the system may includeone or more aspects in accordance with the present disclosure to detecta tumor and/or lesion along an organ wall (e.g., along a bladder wall),excising and/or ablating a suspected tumor and/or lesion in accordancewith the present disclosure. Such means may include tone monitoringaspects, visual feedback from an associated camera system, alteredelectrophysiological activity thereby, etc.

A system in accordance with the present disclosure may include adelivery system (e.g., a minimally invasive catheter, a tubular deliverysystem, etc.), configured for entry into a hollow organ (e.g., abladder, uterus, etc.), via a port (e.g., a urethra, a vagina, etc.).The catheter may include and/or interface with one or more sensing tips,probes, and/or microfingers in accordance with the present disclosure.

The delivery system may include a delivery catheter with a diameter lessthan 10 mm, less than 6 mm, less than 4 mm, less than 2 mm, so as to fitthrough a port and interface with an associated organ.

In aspects, the delivery system may include one or more featuresconfigured to retain, register, and/or otherwise keep the deliverysystem in place within the body during a surgical procedure. Somenon-limiting examples of such features include one or more anchors, aMalecot wing tip, J-stent, basket feature, DePezzer mushroom tip, aFoley balloon, registration markings, tolerance lines, contrastmarkings, embossed indicators, combinations thereof, and the like.

In aspects, the delivery system may include one or more balloons,configured to register and anchor the delivery system at the urethralentrance to an associated bladder during a surgical procedure.

In aspects, the delivery system may include one or more microfingers,balloons, meshes, combinations thereof, or the like each in accordancewith the present disclosure.

In aspects, a system in accordance with the present disclosure mayinclude a single or multi-lumen sheath with a balloon attached towards adistal end thereof (e.g., towards an end that is inserted into a body).The balloon may have a plurality of electrical elements and/or sensingtips in accordance with the present disclosure arranged around the outersurface thereof. In aspects, the balloon may be expandable so as to biasthe electrical elements embedded thereupon against the bladder wall,and/or to effectively fill the bladder during the procedure.

In aspects, one or more electrical elements included in the tool,balloon, etc. may be interconnected with a control unit, so as toprovide a combination of feedback (e.g., biosignal sensing, stiffnesssensing, etc.) and/or actuation (e.g., ablation, movement, etc.)capabilities, or the like.

In aspects, a system for monitoring, electrophysiologically mapping,and/or electrically pacing an organ (i.e., a bladder) in accordance withthe present disclosure includes one or more sensing tips in accordancewith the present disclosure for interfacing with the organ walls, and/oran entry port (i.e., a urethra) before, during, and/or after aprocedure. In aspects, such sensing tips may include microsensorelectrodes, electrode strips, mechanomyographic sensors, stiffnesssensors, impedance sensors, combinations thereof, or the like each inaccordance with the present disclosure.

In aspects, one or more sensing tips/electrodes may be configured fordelivering a stimulation and/or a therapy (e.g., RF ablation, microwaveablation, etc.), to one or more tissue sites within the organ, and/orentry port. In aspects, arrangements may be suitable for performinglocal ablations, strip ablations, ablating odd shaped regions of theorgan wall, ablating arbitrarily programmable regions of the organ wall(i.e., as determined necessary via feedback monitoring thereof, via atest procedure, etc.). Such ablation may be scoped, and/or completedbased upon and/or with feedback from sensors

In aspects, before, during, and/or after an ablation procedure, a localflow of fluid may be provided so as to minimize damage, char, etc. thatmay form during the procedure.

In aspects, a system in accordance with the present disclosure mayinclude a counter electrode configured and dimensioned for placementwithin the entry port, the organ, in the vicinity of the organ, in anadjacent organ (i.e., a vaginally, or rectally placed counter electrode,etc.). In aspects, the counter electrode may be configured as areference electrode for monitoring electrophysiological activity as partof a procedure in accordance with the present disclosure, as a counterelectrode for use in facilitating an RF ablation procedure, combinationsthereof, or the like.

In aspects, one or more RF ablation currents may be directed between twoor more electrodes included in a system in accordance with the presentdisclosure. Thus a local, programmable current patch may be configuredbetween electrodes in communication with a local tissue site in thebody. The electrodes selected for current flow may be selected based onfeedback, determination of abnormal electrophysiological activity (i.e.,at one or more sites along a target organ, etc.). Such a configurationmay be advantageous to limit delivery of therapeutic currents to aregion of diseased tissue, a target treatment site, etc.

In aspects, additional electrodes may be placed at remote sites withinor on the body to facilitate additional monitoring pathways, ortherapeutic current flow pathways during a procedure.

A method for scanning one or more anatomical sites within a body foroveractive and/or irregular tissue behavior (i.e., abnormalphysiological and/or electrophysiological activity) in accordance withthe present disclosure may include biasing one or more electrodeelements towards the wall of an organ (i.e., a bladder, a uterus, etc.)and assessing the electrophysiological activity thereof. In aspects, themethod may include determining if the electrophysiological activity isabnormal (i.e., overactive, erratic, overly sensitive to stimuli, etc.).In aspects, the method may include deciding upon whether to mark (i.e.,mark with an identifying feature for future reference, etc.), treat(i.e., to treat the tissues with a method in accordance with the presentdisclosure), to treat immediately with the electrodes used in theassessment, etc. In aspects, the method may include treating the tissuewithout removing the surgical tool from the body of the subject betweenprocedures (i.e., between assessing, testing, and treating one or moresites within the body).

In aspects, the method may include monitoring physiological response atone or more remote locations in the body (physically removed from theorgan) in conjunction with a stimulation or test. In aspects, the methodmay include stimulating one or more tissues to determine the location ofproprioceptive nerve endings for potential treatment.

In aspects, one or more abnormal sites (i.e., as determined by anassessment, etc.) may be selectively treated so as to augment (i.e.,adjust) the overall behavior of the bladder during regular filling andvoiding procedures.

In aspects, the method may include mapping one or more sites using asystem in accordance with the present disclosure. In aspects, themapping results may be may be used to selectively ablate and/ordenervate regions of the bladder wall, selectively reduce neurologicalinterconnection to one or more regions of the bladder, etc.

In aspects, the method may include assessing pain, bladder related pain,etc. with a system in accordance with the present disclosure. The methodmay include stimulating one or more sites within the organ or along aneurological feature connected thereto while assessing a subjectresponse thereto. In aspects, the method may include questioning what asubject is feeling during a stimulation event, evaluating the degree ofsensation being felt by the subject, etc.

The method may include monitoring physiological and/orelectrophysiological signals at one or more sites within the organ(i.e., bladder, along a wall of the bladder, etc.) or one or moreneurological features connected thereto, while performing a urodynamicprocedure (i.e., filling the bladder with a fluid, voiding the bladder,having the subject attempt to urinate, etc.).

In aspects, a system in accordance with the present disclosure may beused to diagnose the proprioceptive sites for pain registration in thebladder. Such testing may be performed via actively stimulating sitesalong the bladder wall, while monitoring patient feedback, discomfort,pain levels, etc. Such testing may provide a means for locating abnormaltissue sites, potentially responsible for generating the pain signals.Treatment of such sites may be performed in combination with testing. Inaspects, a method related thereto may include generating a metric basedupon the extent of electrophysiological activity experienced during aurodynamic procedure, and at least partially assigning the diagnosisbased upon the metric.

In aspects, treatment of one or more sites within the organ or on aneurological feature connected thereto may be performed in single stepsor staged (i.e., performed over a sequence of steps). In aspects, astaged treatment may include applying a bolus of energy to treat one ormore sites (i.e., a first bolus with a reversible energy level, a lowenergy level, etc.), so as to determine if the correct site is beingtreated. In order to assess the site, the energy bolus may be appliedlocally to a level sufficient to temporarily disrupt function of thelocal tissues, but not provided in a sufficient amount to causeirreversible damage thereto. In aspects, upon confirmation of adesirable change in function after application of the first bolus ofenergy, a second bolus of energy, suitable for implementing anirreversible treatment may be applied (e.g., a high energy ablation asopposed to a low energy ablation).

In aspects, staged treatment may also take place over a plurality ofspatially separated regions of the bladder. In aspects, the treatmentmay be applied strategically to regions of the bladder, perhaps thoseregions that respond most dramatically to the testing regiment, or thoseregions that are most active. The treatment may continue along the wallof the bladder until a suitable change in activity has been observed.

In aspects, a system in accordance with the present disclosure mayinclude pressure sensitive elements, stretch elements, etc. In aspects,the combination of signals derived from such elements in combinationwith a filling procedure (i.e., a urodynamic procedure), the results ofwhich may be suitable for determining tone of the bladder wall, changesin tone with filling, local differences in tone (i.e., as may be causedby a local lesion or tumor), etc.

In aspects, a method and/or a system in accordance with the presentdisclosure may be used to treat a patient suffering from overactivebladder.

FIGS. 1a-b show aspects of a surgical tool 100 placed within a urinarybladder 2 in accordance with the present disclosure. FIG. 1a showsaspects of a surgical tool 100 placed into a bladder 2 of a subject viathe urethra 1 of the subject. In the example shown, the subject isfemale and shown for reference is the vagina 3, the uterus 4, and therectum 5. The surgical tool 100 (i.e., a monitoring tool, a treatmentdevice, etc. in accordance with the present disclosure) includes adelivery system 110 in accordance with the present disclosure configuredand dimensioned so as to traverse through the urethra 1 into the bladder2 during an insertion procedure. The surgical tool 100 includes aballoon 105 fastened thereto. The balloon 105 includes one or moresensing tips each in accordance with the present disclosure, configuredso as to bias towards a wall of the organ upon expansion of the balloonthere within. The surgical tool 100 includes a port 115 configured toprovide fluid exchange between a distal and proximal end thereof (i.e.,in the example shown, so as to fill the balloon 105 during an inflationprocedure, or deflate the balloon 105 during a deflation procedure).

The surgical tool 100 may be coupled in mechanical, fluid, and/orelectrical communication 120 with a controller (not explicitly shown)for performing one or more aspects of the procedure. In aspects, thesurgical tool 100, in this case, the delivery system 110 may include oneor more sensors in accordance with the present disclosure. As shown inFIG. 1a , the delivery system 110 may include an electrode 125 (i.e., acounter electrode, a reference electrode, etc.) positioned along thelength thereof and electrically coupled with the controller. In aspects,the electrode 125 may be positioned along the delivery system 110 so asto interface intimately with a sphincter (i.e., a urethral sphincter,etc.) after placement for a surgical procedure. The electrode 125 may beconfigured to stimulate and/or monitor electromyographic activity inlocal tissues during a procedure (i.e., during a urodynamic test, astimulation process, an ablation process, etc.). In aspects, theelectrode 125 may be configured as a counter or reference electrode foruse in conjunction with one or more sensing tips situated on the balloon105. In aspects, the surgical tool 100 may be configured so as to passan RF current from one or more sensing tips situated on the balloon 105to the electrode 125. In aspects, the surgical tool 100 may beconfigured so as to monitor electrophysiological activity at one or moresensing tips on the balloon 105 with reference to the electrode 125.

FIG. 1b illustrates the surgical tool 100 placed within the bladder 2 ofa subject, engaged 120 in fluid, and electrical communication with acontroller (not explicitly shown). A bolus of fluid was delivered to thesurgical tool 100 and filled the balloon 105′ via the delivery system110 and the port 115 so as to engage the balloon 105′ with the wall ofthe bladder 2. In aspects, the balloon 105′ may have been filled so asto provide a pressure P against the walls of the bladder 2. In aspects,the pressure P may be less than 50 mmHg, less than 30 mmHg, less than 10mmHg, less than 5 mmHg, or the like. In aspects, the balloon 105′ mayinclude one or more sensing tips in accordance with the presentdisclosure to measure the applied pressure P. In aspects, the balloon105′ may include one or more sensing tips in accordance with the presentdisclosure to monitor one or more physiological and/orelectrophysiological signals along the walls of the bladder 2. Inaspects, such monitoring may be to elucidate one or more regions 130 a-ialong the bladder wall 2 with abnormal physiological behavior (i.e.,abnormal electrophysiological activity, abnormal sensory response to anapplied pressure P, etc.). Such regions 130 a-i may be designated assites for treatment. In aspects, the surgical tool 100 may be configuredto treat one or more of the regions 130 a-i via one or more sensing tipsincluded in the balloon 105′. In aspects, the treatment of the regions130 a-i may be performed via one or more electrodes included in theballoon 105′. In aspects, the surgical tool 100 may be configured so asto pass an RF current from one or more sensing tips situated on theballoon 105′ to the electrode 125. In aspects, the surgical tool 100 maybe configured so as to monitor electrophysiological activity at one ormore sensing tips on the balloon 105′ with reference to the electrode125.

In aspects, a sensing tip in accordance with the present disclosureincluding one or more piezoresistive materials may be configured tomeasure a local contact pressure between the balloon and the wall of theorgan. Such measurements may be performed in conjunction with themonitoring so as to relate local stresses (i.e., embodied in localtissue strains, etc.) with electrophysiological activity in the relatedtissues. Such relationships may be used in the formation of a metric fordiagnosing a disease state, determining if a tissue site is a candidatefor therapy, determining if a therapy has been successful, etc.

FIG. 2 shows aspects of a surgical tool 200 in accordance with thepresent disclosure. The surgical tool 200 includes a delivery system 210in the shape of an elongate structure (i.e., in this case a tubularstructure) including one or more lumens 235 therein suitable forplacement of the surgical tool 200 within a cavity of a subject, forcommunicating mechanically, electrically, or for delivering fluid 222between a proximal and distal end thereof as part of a procedure inaccordance with the present disclosure. In aspects, the surgical tool200 may include a maneuverable tip (also 210), which may be orientedwithin the organ once placed therein. The delivery system 210 mayinclude one or more ports 215 for fluid delivery there between. Thedelivery system 210 includes cabling 240 (i.e., wires, a printed circuittraces, etc.) for providing the electrical communication 222 between thecontroller and one or more sensing tips or electrodes 225 located on thesurgical tool 200.

FIG. 2 illustrates a balloon 205, 205′ in accordance with the presentdisclosure (i.e., equivalently a deployable mesh-like structure), theballoon 205, 205′ including one or more sensing tips 245 each inaccordance with the present disclosure, suitable for interfacing withtissues adjacent thereto during a procedure. The balloon 205, 205′ isshown in a delivery state 205 (i.e., a state suitable for passagethrough an entry port to the organ), and an expanded state 205′ (i.e., astate suitable for interfacing with tissues in the organ). In theexample shown, the balloon 205 is pleated 250 around the shaft of thedelivery system 210 in the delivery state.

In aspects, the balloon 205, 205′ may include a plurality of sensingtips 245 configured over the surface thereof. In aspects, the sensingtips 245 may be configured to monitor highly local anatomical sites(i.e., via one or more microelectrode aspects), or to monitor amacroscopic region of the organ wall (i.e., via one or moremacroscopically oriented electrode aspects). FIG. 2 illustrates a seriesof sensing tips 245 arranged along the balloon 205′ to measureelectrophysiological activity over a region 265 of the surface thereof.

In aspects, a series of microelectrode sensing tips may be configuredand arranged so as to monitor local activities (i.e., designated byindividual + and − symbols in the figure), or so as to collectivelymonitor activity representative of the entire region 265 (i.e., via asummation process, etc.). Such a configuration may be advantageous fordetermining if a region along an organ wall needs further treatment,etc. In aspects, the sensing tips 245 may be used to provide treatmentto such regions 265, or microscopic sites within. Such treatment may beprogrammably configured based upon an earlier sensing operation, or thelike.

In aspects, a series of sensing tips 245 in accordance with the presentdisclosure may be arranged and configured along the balloon 205′ tomeasure local tissue compliance 255 within a region 260 of an organadjacent thereto (i.e., during a filling procedure, a urodynamic test,etc.).

FIG. 3 shows aspects of a balloon wall 305 in accordance with thepresent disclosure. The balloon wall 305 includes one or more sensingtips in accordance with the present disclosure. The balloon wall 305includes a plurality of electrodes 330 in accordance with the presentdisclosure. The electrodes 330 are arranged in a cluster 315 along theballoon wall 305 arranged on the outer face thereof so as, to interfacewith adjacent tissues when the balloon 305 is biased there against(i.e., during a surgical procedure, etc.). The electrodes 330 areelectrically interconnected with one or more aspects of an associatedsurgical system (i.e., interconnected with a delivery system, amicrocircuit, a connector, a controller, etc.) via one or moreelectrical traces 325. In aspects the electrical traces 325 may bestretchable, isolated from the surrounding media (i.e., via an overcoat,etc.), or the like.

The balloon 305 has a wall thickness 320. In aspects the wall thickness320 may be less than 200 um thick, less than 100 um thick, less than 50um thick, less than 30 um thick, less than 20 um, less than 10 um, lessthan 4 um, less than 1 um, etc. In aspects the balloon wall 305 mayinclude a stretchable, substantially elastic material so as toaccommodate expansion during a deployment procedure. In aspects, theballoon wall 305 may include one or more composites of somewhat stiffermaterials (such as polyimide, PET, PEN, etc.) and somewhat softermaterials (e.g., silicones, polyurethanes, thermoplastic elastomers,etc.) to compromise between overall structural stiffness and conformalcapabilities of the wall, or to allow for asymmetric expansion thereofduring a deployment procedure.

In aspects, the balloon wall 305 may include an interfacial pressuresensing tip 340 configured to monitor a pressure 350 applied thereto inaccordance with the present disclosure. The pressure sensing tip 340 maybe coupled with one or more aspects in the system via one or moreinterconnects 345. In aspects, the pressure sensing tip 340 may includea piezoresistive material, a strain sensitive material, a nanomaterialbased material (i.e., a whisker based material in accordance with thepresent disclosure), etc.

In aspects, the balloon wall 305 may include an optical sensing tip 360in accordance with the present disclosure. In aspects, optical sensingtip 360 may be equipped with a corresponding micro-light source (e.g.,an oLED, an LED, etc.). The micro-light source may be used to directlight 370 into the adjacent tissues. One or more optical sensing tips360 may be equipped with optical microsensors configured to detect light375 emitted from the micro-light source as back scattered by and/ortransmitted through the adjacent tissues. Such information may be usedto detect anatomical features (e.g., nerves, tumors, etc.) in theadjacent tissues, monitor local fluids (i.e., water content, blood flow,etc.), interact with tissue visualizing materials, for inspectingtissues within the organ wall, etc. In aspects the optical sensing tip360 may be interconnected with another aspect of the system via one ormore electrical traces 365 in accordance with the present disclosure.

In aspects, one or more sensing tips 330, 340, 360 may include amicrocircuit in accordance with the present disclosure. The microcircuitmay be configured to manage signal acquisition, communicate with aspectsof the system, etc.

FIGS. 4a-c show aspects of substrates 405, 425, 450, 470 or equivalentlyaspects of a balloon wall in accordance with the present disclosure.FIG. 4a shows a substrate 405 with an arrangement of electrodes 415 a-c,420 a-f and electrical traces 417 attached thereto, configured toelectrically interconnect 430 the electrodes with one or more aspects ofa system in accordance with the present disclosure. The substrate 405 isshown with an arrangement of point sized electrodes 420 a-f configuredand dimensioned to interface (i.e., monitor local fields and/or deliverycurrent thereto, etc.) with adjacent tissues over a relatively smalldistance. The substrate 405 also includes multiple elongate electrodes415 a-c configured and dimensioned to interface with adjacent tissuesover a relatively large distance.

FIG. 4b illustrates aspects of a substrate 425 with attached electricaltraces 430 in accordance with the present disclosure. The electricaltraces 430 are coated in regions by an insulating layer 435, and may beexposed in regions 440 to form electrodes for interfacing with adjacenttissues. The exposed regions 440 may be coated with one or moreadditional electrode materials to improve the interface with adjacenttissues, store one or more medications, etc.

FIG. 4d shows aspects of a substrate 450 with attached electrical traces455 in accordance with the present disclosure. The electrical traces 455are coupled with a sensing tip 465 in accordance with the presentdisclosure. In aspects, the electrical traces 455 and/or regions of thesubstrate may be covered with an insulating layer 460 to isolate themfrom the adjacent environment, etc.

FIG. 4d shows aspects of a substrate 470 including an electrode with aplurality of whiskers 495 in accordance with the present disclosure. Thesubstrate 470 may include one or more whisker-like structures 495extending from an electrode element 490 included or exposed on thesurface of the substrate 470 (i.e., collectively forming a sensing tipin accordance with the present disclosure). The electrode element 490may be electrically interconnected 480 with a circuit element elsewherein the tool, perhaps a local microcircuit, etc. Such electricalinterconnects 475 may be provided by a flexible circuit, wiring,cabling, etc. The substrate 470 may be configured such that one or moreof the electrical interconnects 475 may be situated substantially at theneutral axis of the tool (i.e., so as to minimize stress thereuponduring bending of the substrate 470). The tool may include insulatingregions 485 configured for similar purposes, and/or as ways to definethe extent of the electrode element 490 on the substrate 470 surface.

In aspects, one or more of the whiskers 495 may be formed frommicrofibers, nanofibers, microneedles, nanoneedles, etc. In aspects, oneor more whiskers 495 may be formed from a carbon structure, e.g., acarbon fiber, a carbon nanotube, etc. In aspects, the whiskers 495 maybe insulated along a portion of their length, with an electricallyexposed region at the tip there upon.

The whiskers 495 may be configured with sufficient strength so as topenetrate into a tissue structure when biased there against. Thewhiskers 495 may be configured such that the tips may penetrate into anadjacent nerve structure, a nerve bundle, a nerve cell body (oftencalled the soma), a dendrite, an axon, a cable-like bundle of neuralaxons, the endoneurium, a fascicle, an epineurium, and/or a perineuriumduring a procedure. Such a configuration may be advantageous formonitoring a neuronal signal from a more highly selective tissue site,than would be achievable with an associated macroscopic electrode.

FIGS. 5a-b show aspects of a surgical tool with flexible wire elementsin accordance with the present disclosure. FIG. 5a shows a surgical toolincluding a delivery sheath 510 and a delivery member 505 (i.e.,collectively a delivery system in accordance with the presentdisclosure). The delivery sheath 510 may be retractable 530 so as toexpose more or less of the delivery member 505 during a deploymentprocedure. The delivery member 505 may be coupled with one or moremicrofingers 515 each in accordance with the present disclosure. Themicrofingers 515 may include one or more sensing tips 520 each inaccordance with the present disclosure. In aspects, the delivery member505 may be coupled with a cap 525 arranged so as to protect one or moresensing tips 520 during an insertion procedure. In aspects, the cap 525may be slide ably 535 mounted on the delivery member 505 so as to allowfor deployment of one or more microfingers 515 into the organ during adeployment procedure.

FIG. 5b illustrates aspects of the surgical tool with the cap 525′adjusted 540 along the length of the delivery member 505′ so as toexpose the sensing tips 520′ and allow for deployment of themicrofingers 515′ so as to interface one or more of the sensing tips520′ with an adjacent organ wall 2. In aspects, the delivery member 505′may include a port 550 for communicating fluids between the organ 2interior and a controller (not explicitly shown). Such fluid exchangemay be suitable for adjusting the internal volume of the organ, removingfluids from the organ, providing coolant to the organ interior, etc.

In aspects, the delivery member 505′ may be actuate able, and/oradjustable about an axis of the delivery sheath 510′ so as to rotate545, and/or sweep one or more of the sensing tips 520′ along the organwall 2.

FIG. 6 shows aspects of a surgical tool with a deployable substrate 645in accordance with the present disclosure. The surgical tool includes adelivery sheath 615 and a delivery member 610 (collectively forming adelivery system in accordance with the present disclosure) arranged downa lumen within the delivery sheath 615. The delivery member may includea port 635 for fluid exchange between distal and proximal ends thereof.The tool may include a substrate 645 generally wrapped around thedelivery member 610 so as to form a structure with a sufficiently smalldiameter to enter the organ through a port (i.e., a urethra). Inaspects, the delivery sheath 615 may be retractable along the length ofthe delivery member 610 so as to deploy the substrate 645 within theorgan so as to bias 650 the substrate 645 against a wall thereof. Thesubstrate may include one or more electrical and/or optical traces 620,630 for communicating 625 between one or more aspects of the tool and acontroller, connector, etc. In aspects, the substrate 645 may includeone or more sensing tips 640 (in this aspect shown as electrodes), andoptionally one or more microcircuits 655 in accordance with the presentdisclosure coupled with the sensing tips 640 and the traces 620, 630.

In aspects, the microcircuit 655 may be configured so as tosubstantially reduce the number of signal wires that must be sent to thesurgical site during the procedure. A networked array of sensing tipsmay be multiplexed together with a locally placed microcircuit 655(e.g., an application specific integrated circuit,distributed/interconnected circuit elements, a collection of flexiblesemiconducting circuit elements, etc.). The microcircuit 655 may beconfigured to communicate such signals with an extracorporeal system(e.g., a computer, a control system, an RF ablation controller, a dataacquisition system, etc.). The microcircuit 655 may be configured tocommunicate with the extracorporeal system via analog and/or digitalmeans and/or methods. In aspects, the communication may be of primarilydigital means such that the microcircuit may exchange data pertaining toany sensing tip in the array, as well as switch data, control data, RFpulse routing, etc.

FIG. 7a-d show aspects of a surgical tool with deployable mesh 710 inaccordance with the present disclosure. The mesh 710 may include one ormore fibers 715, 720 (i.e., fulfilling the function of microfingers inaccordance with the present disclosure). The fibers 715, 720 may beconfigured to carry an electrical current and be coupled 730 with acontroller, microcircuit, connector, etc. in accordance with the presentdisclosure. The fibers 715, 720 may be addressable such that fibers 715arranged in a longitudinal direction a-e may be addressed independentlyof fibers 720 arranged in a cross direction. Thus interconnection forpurposes of monitoring and/or applying currents to a site in the bodymay be programmatically adjusted during use (i.e., so as to direct astimulating and/or ablation current to a site on the mesh 710, tomonitor at one or more sites on the mesh 710, etc.). In aspects the mesh710 may be configured so as to deploy 735 outwards from a deliverysheath when deployed into an organ of interest. In aspects the mesh 710may include one or more sites 725 wherein sensing, current delivery,etc. may be programmatically adjusted during use.

FIG. 7b shows aspects of a site 725 whereby multiple fibers 715, 720 ina mesh 710 come nearest together in an application. The fibers mayinclude one or more exposed regions so as to allow for electricalcommunication of currents 740, 745, 750, 755 there between during use.

FIG. 7c illustrates a surgical tool 760 in accordance with the presentdisclosure including one or more fibers 770 and restrained within adelivery sheath 765. The fibers 770 may be provided in electrical and/ormechanical communication 775 with a controller, connector, and/ormicrocircuit in accordance with the present disclosure.

FIG. 7d shows the surgical tool 760 after the deployment of a mesh 782from within a retractable delivery sheath 765′. The mesh 782 includes aplurality of fibers 770, 774 for interacting with the surroundingtissues of an organ. The mesh 782 may be configured so as to expand 777outwards upon deployment from the delivery sheath 765′.

In aspects, the mesh 782 may include one or more shape control points772, 779 configured so as to help restrain the shape of the mesh 782during a deployment procedure in a body.

The fibers 770, 774 may be provided in electrical and/or mechanicalcommunication 775 with a controller, connector, and/or microcircuit inaccordance with the present disclosure.

FIG. 8 shows aspects of a surgical tool 800 with a counter electrode 840in accordance with the present disclosure. The surgical tool 800 (i.e.,a monitoring tool, a treatment device, etc. in accordance with thepresent disclosure) includes a delivery system 810 in accordance withthe present disclosure configured and dimensioned so as to traversethrough the urethra 1 into the bladder 2 during an insertion procedure.The surgical tool 100 includes a balloon 805′ fastened thereto. Theballoon 805′ includes one or more sensing tips each in accordance withthe present disclosure, configured so as to bias towards a wall of theorgan upon expansion of the balloon 805′ there within. The surgical tool800 includes a port 815 configured to provide fluid exchange between adistal and proximal end thereof (i.e., in the example shown, so as tofill the balloon 805′ during an inflation procedure, or deflate theballoon 805′ during a deflation procedure).

FIG. 8 illustrates the surgical tool 800 placed within the bladder 2 ofa subject, engaged 820 in fluid, and electrical communication with acontroller (not explicitly shown). A bolus of fluid was delivered to thesurgical tool 800 and filled the balloon 805′ via the delivery system810 and the port 815 so as to engage the balloon 805′ with the wall ofthe bladder 2. In aspects, the balloon 805′ may have been filled so asto provide a pressure P against the walls of the bladder 2. In aspects,the pressure P may be less than 50 mmHg, less than 30 mmHg, less than 10mmHg, less than 5 mmHg, or the like. In aspects, the balloon 805′ mayinclude one or more sensing tips in accordance with the presentdisclosure to measure the applied pressure P. In aspects, the balloon805′ may include one or more sensing tips in accordance with the presentdisclosure to monitor one or more physiological and/orelectrophysiological signals along the walls of the bladder 2. Inaspects, such monitoring may be to elucidate one or more regions 830 a-ialong the bladder wall 2 with abnormal physiological behavior (i.e.,abnormal electrophysiological activity, abnormal sensory response to anapplied pressure P, etc.). Such regions 830 a-i may be designated assites for treatment. In aspects, the surgical tool 800 may be configuredto treat one or more of the regions 830 a-i via one or more sensing tipsincluded in the balloon 805′. In aspects, the treatment of the regions130 a-i may be performed via one or more electrodes included in theballoon 105′. In aspects, the surgical tool 800 may be configured so asto pass an RF current from one or more sensing tips situated on theballoon 805′ to the electrode 825. In aspects, the surgical tool 800 maybe configured so as to monitor electrophysiological activity at one ormore sensing tips on the balloon 805′ with reference to the electrode825.

In aspects, the surgical tool 800 may be configured so as to pass acurrent i₁, i₂ (a DC current, an RF current, a stimulating current, aheating current, an ablating current, etc.) between one or more sensingtips on the balloon 805′ and the counter electrode 840 (i.e., via one ormore electrode patches 850 a,b included therein, to the counterelectrode 840 on the whole, etc.). The counter electrode 840 may becoupled 845 with a controller, a connector, a microcircuit, etc. inaccordance with the present disclosure. In aspects, the counterelectrode 840 may be configured and dimensioned for placement within anadjacent orifice of the body, a vagina, a rectum, etc. to facilitatecommunication with the surgical tool 800 during a procedure.

In aspects, a sensing tip in accordance with the present disclosureincluding one or more piezoresistive materials may be configured tomeasure a local contact pressure between the balloon and the wall of theorgan. Such measurements may be performed in conjunction with themonitoring so as to relate local stresses (i.e., embodied in localtissue strains, etc.) with electrophysiological activity in the relatedtissues. Such relationships may be used in the formation of a metric fordiagnosing a disease state, determining if a tissue site is a candidatefor therapy, determining if a therapy has been successful, etc.

FIG. 9 shows aspects of a surgical tool 900 in conjunction with one ormore remote monitoring sites 920 a-d placed upon a subject 6 inaccordance with the present disclosure. The surgical tool 900 may beplaced within the subject 6 (i.e., so as to access at least a portion ofan organ within the subject 6) as part of a surgical procedure. Thesurgical tool 900 may be configured to communicate 910 with acontroller, a connector, a microcircuit (not explicitly shown) and tomonitor and/or treat one or more adjacent tissues within the body inconjunction with the remote monitoring sites 920 a-d. The remotemonitoring sites 920 a-d may be coupled 930 in electrical communicationwith the same controller, or microcircuit in order to provide areference, a counter electrode, etc. for a procedure performed on thesubject 6.

Such remote monitoring sites 920 a-d may be arranged so as to monitorone or more electromyographical signals associated with pelvic muscles,the bladder, abdominal muscles, a peripheral nerve signal, etc. as partof a procedure in accordance with the present disclosure.

In aspects, such a configuration may be advantageous for generalmonitoring of a subject 6 (i.e., as part of a diagnostic procedure, partof a follow up procedure, etc.), as part of a urodynamic test performedon the subject 6, etc.

FIG. 10 shows a urinary bladder 2 with non-limiting examples oftreatment patterns 1010 a-e, 1020, 1030, 1040 thereupon. The patterns1010 a-e, 1020, 1030, 1040 may be formed with a system, surgical tool,and/or one or more sensing tips in accordance with the presentdisclosure. The bladder wall 2 may be treated with one or more spottreatment patterns 1010 a-e so as to treat reasonably confined regionsof abnormal tissue behavior. In aspects, the bladder wall 2 may betreated with one or more track-like patterns 1020 so as to disconnect aregion of abnormal electrophysiological behavior from a region ofnormally functioning tissues, from an associated neural circuit, etc. Inaspects, the bladder wall 2 may be treated with a through-wall pattern1030 of controlled depth into the wall of the organ. In aspects, thethrough-wall patterned 1030 treatment site may be controlled, so as tolimit damage to the mucosal and adventitial layers of the organ wall(i.e., focused so as to affect primarily the muscular layers of theorgan wall). Such control may be obtained with coolant mitigated RFablation currents, a bolus of chemical agent delivery into the wall,etc.

In aspects, one or more regions 1040 around the bladder neck and/or theurethra 1 may be treated so as to form substantially circumferentialtreatment pattern there-around.

In aspects, the regions 1010 a-e, 1020, 1030, 1040 treated during aprocedure in a particular subject may be compared with regionspreviously treated in that subject, across a patient population, etc. soas to determine typical areas of abnormal behavior, outcomes, etc.

FIG. 11 shows a graphical display of the relationship between localneurological activity and bladder fill volume before 1110, during 1120,and after 1130 treatment with a device in accordance with the presentdisclosure. The relationship shows micturition onset for a pretreated1140 and post treated 1150 subject, demonstrating the effect of thesurgical procedure on the bladder storage capacity thereof. In aspects,a procedure in accordance with the present disclosure may includeassessing the micturition volume for a subject at intervals during asurgery to determine whether to continue with a surgery, to stop, toadjust the treatment site, etc.

FIGS. 12a-d show aspects of methods for using a surgical tool inaccordance with the present disclosure. FIG. 12a shows a method fortreating a tissue site within a subject including inserting 1201 one ormore electrodes and/or sensing tips into the subject, biasing 1203 theelectrodes and/or sensing tips against the wall of an organ in thesubject so as to interface with the tissues thereby, optionallystimulating 1205 the tissues with one or more of the electrodes and/orsensing tips, and monitoring 1207 the physiological and/orelectrophysiological activity and/or response (i.e., to the optionalstimulation 1205) to assess the functionality of the adjacent tissues.The method may also include treating 1209 (i.e., ablating, denervating,performing a neuromodulation procedure, cryoablating, ultrasonicallydisrupting, magnetically heating, etc.) on the tissues and determiningif the procedure has been completed (i.e., such as by performing furtherstimulation, monitoring, etc.). If the procedure has been completed, themethod may include optionally testing 1211 the subject to determine ifthe surgical procedure was successful or completed. If not, the methodmay include repeating one or more steps, if completed the methodincludes removing the electrodes and/or sensing tips from the subject.

FIG. 12b shows a method for treating a subject in accordance with thepresent disclosure including interfacing 1213 an electrode and/orsensing tip in accordance with the present disclosure with a targettissue (i.e., a tissue associated with the urological system of asubject), and performing a urodynamic test 1215 to determine one or morephysiological responses of the subject, to monitor target tissues duringsuch a test, etc. The method includes reversibly treating 1217 tissuesof, the subject to determine if the correct treatment site has beenselected, to assess the potential outcome of such a procedure, etc. Themethod may include 1219 optionally retesting the subject so as to see ifthe urodynamic test yields new results. If the test results haveimproved, permanently treating 1221 the target tissues, if not,adjusting the site of or one or more parameters of the therapy 1223 andrepeating one or more steps in the method.

FIG. 12c illustrates aspects of a method for sequentially treating oneor more target sites in an organ of a subject including analyzing 1231function on tissues in the vicinity of a potential surgical site, if thetissue function is found to be abnormal treating 1233 the tissues with asurgical procedure in accordance with the present disclosure, if not,adjusting the treatment site 1239 to analyze additional tissues in theorgan. If the treatment 1233 is completed, the method may includeretesting 1235 the subject to determine if further treatment isnecessary, if not, determining if the procedure has been completed or ifmore sites are to be treated. If the procedure has been completed,finishing the procedure 1237.

FIG. 12d illustrates aspects of a procedure for testing and/or treatinga subject in accordance with the present disclosure including insertinga catheter 1251 into the subject so as to access the bladder thereof,changing the pressure 1253 within the bladder and monitoring 1255 theresponse thereto (i.e., monitoring one or more physiological and/orelectrophysiological responses to the change in pressure), optionallytreating 1257 one or more sites within the bladder, and optionallytesting 1259 to determine if the treatment was successful. The methodmay include comparing the pressure changes to the electrophysiologicaland/or physiological activity to determine the functional state of oneor more tissue sites within the bladder, to facilitate a diagnosticdecision about a disease state of the subject, etc.

Other aspects of methods, variants thereof, etc. are discussedthroughout the disclosure.

FIGS. 13a-c show aspects of a surgical tool in accordance with thepresent disclosure. FIG. 13a shows aspects of a balloon 1305 catheterconfigured for accessing the neck of a bladder, the balloon 1305including one or more interconnects and associated sensing tips 1315 inaccordance with the present disclosure attached thereto (i.e., patternedthereupon, laminated thereto, attached thereto, etc.). In aspects, theballoon 1305 may be deployed 1330 within the bladder so as to bring oneor more of the sensing tips 1315 into intimate contact with the wallsthereof. The sensing tips 1305 may be optically and/or electricallycoupled 1320 with a controller, a connector, a microcircuit, etc. whilethe balloon interior may be provided in fluid communication 1325 with aconnector, controller, a fluid reservoir, etc.

FIG. 13b shows aspects of an interconnect 1335 configured with one ormore sensing tips 1340 in accordance with the present disclosure. Theinterconnect 1335 is configured for electrical and/or opticalcommunication between the sensing tips 1340 and one or more aspects ofan associated system.

FIG. 13c shows aspects of an interconnect 1350 including a plurality of(in this non-limiting example) exposed and coupled electrodes 1355 a-din accordance with the present disclosure (i.e., patterned so as toadjust the current flow there between during an ablation procedure,etc.). In aspects, the interconnect 1350 includes one or more insulatingregions 1360 a-e configured so as to isolate the underlying traces fromthe surrounding environment.

In aspects, the balloon 1305 may include one or more perforations and ormicroinjection ports configured such that a medicament may be deliveredto the adjacent tissues or a surgical site in accordance with thepresent disclosure.

FIG. 14 shows aspects of a device 1400 for assessing local physiologicalresponse and/or treating a local tissue site 1440 in accordance with thepresent disclosure. The device 1400 includes a delivery system includingan optional delivery sheath 1405 and a delivery member 1410 inaccordance with the present disclosure configured for passage though theurethra 1 to access the bladder 2. The delivery member 1410 extendsbeyond the sheath 1405 so as to enter the bladder 2 and interface withthe tissues thereof. The delivery member 1410 may include an actuateable part 1415 configured so as to move, sweep 1445, etc. within thebladder 2 for accessing one or more tissues sites 1440 along the wallthereof. The delivery member 1410 may include one or more sensing tips1420, 1425, 1430 in accordance with the present disclosure to assessand/or treat one or more tissues sites in and around the organ. Somenon-limiting examples are shown including an electrode 1420, a strainsensing element 1430, and a pressure sensing element 1425. In aspects,the delivery member 1410 may be configured to bias with a force F one ormore sensing tips 1420 against the wall of the bladder 2 at anassessment and/or treatment site 1440.

In aspects, the system may be configured to measure tissue tone at thesite 1440, measure electrophysiological response to pressure changes P,bias force F changes, etc. In aspects, the delivery sheath 1405 mayinclude a retention feature 1435 for maintaining the position thereof inplace during the procedure. In aspects, the delivery sheath 1405 mayaccommodate an externally applied retention feature 1465, configured soas to maintain a strain relief fit between the delivery system and theurethra 1 during a procedure. In aspects, the delivery member 1410and/or the delivery sheath 1405 may include one or more lumensconfigured for fluid communication 1455 between an externally locatedfluid source and the bladder, suitable for fluid exchange 1450 therebetween during a procedure. In aspects, the sensing tips 1420, 1430,1425 may be electrically coupled 1460 with a connector, controller,and/or a microcircuit in accordance with the present disclosure.

In aspects, the system may include one or more electrodes 1420configured to pass a current (i.e., a stimulating current, an ablatingcurrent, a tissue heating current, for purposes of diagnostics,temporary treatments, permanent treatments, etc.) between one or more ofthe electrodes 1420 with one or more aspects of the system and/or acounter electrode 1480 located remotely from the surgical site 1440(i.e., as a body patch, an electrode inserted into the vagina, therectum, a transcutaneously placed electrode, etc.).

Such a tool 1400 may be configured to perform one or more aspects of amethod and/or surgical procedure in accordance with the presentdisclosure.

FIG. 15 shows a graphical relationship between a probe and physiologicalmeasurements performed with a device in accordance with the presentdisclosure. In aspects, the probe may be an aspect of a balloon, adelivery member tip, a wire mesh, etc. in accordance with the presentdisclosure. The relationship under study may pertain to a globalpressure application within the bladder, or a local pressure applicationapplied at the monitoring site, or a site in electrophysiologicalcommunication with the monitoring site. In aspects, the procedure mayinclude applying a stimulus 1505, perhaps a sequence of stimuli, etc. tothe tissue site (i.e., either globally, locally, etc.). Such stimuli mayinclude an electrical impulse, a thermal pulse (i.e., local heating), alocal pressure application (i.e., force from a local probe tip, etc.),or the like. In aspects, the response 1515 to the stimuli 1505 may bemonitored 1520 for purposes of assessment, therapeutic progress,determining regions of abnormal activity, etc. In the non-limitingexample shown, the stimuli 1505 is a local current pulse, applied withan electrode in accordance with the present disclosure. The response1515 is the local pressure measured on the electrode (i.e., applied tothe electrode while biased against the tissues) in response to thestimuli 1505. The electrode is moved slowly 1510 along the surface ofthe tissue as the stimuli 1505 are applied locally thereto.Alternatively, additionally, or in combination the stimuli 1505 may beapplied over a region of the tissues via an array of sensing tips (i.e.,as patterned on a balloon, as part of a brush-like tool, etc.) so as toachieve the same effect as a probe, without the need to move one or moreelements across the tissue surface.

The response 1515 is shown at multiple sites along the tissue surface.As can be seen the change in pressure from a baseline level P₀ isreasonably consistent at a plurality of sites 1525 thereupon but may bedistinctly increased at one or more sites 1530, such sites may becandidates for a surgical procedure, may be indicative of ahypersensitivity, etc. Such information may be used for diagnosticpurposes, to identify suitable surgical sites, to identify the extent ofa surgical procedure, etc.

FIGS. 16a-c show aspects of tip electrode configurations for a surgicaltool in accordance with the present disclosure. FIG. 16a shows anelectrode 1615 coupled with a probe 1610 (i.e., equivalently part of adelivery module, microfinger, etc.) each in accordance with the presentdisclosure. The electrode 1615 may act as a monopolar configuration, forcommunication with one or more electrodes in the system (not explicitlyshown) in order to interface with tissues adjacent thereto during aprocedure. The electrode 1615 may be coupled with 1620 one or moreaspects of a system in accordance with the present disclosure via theprobe 1610.

FIG. 16b shows a delivery module 1630 coupled with two electrodes 1635a,b, each in accordance with the present disclosure. The electrodes 1635a,b are arranged in a bipolar electrode arrangement for interfacing witha local tissue site. Such an arrangement may be advantageous for localfield vectors, movement, a bipolar signal, etc. or for providing acurrent to a precise region of tissue in the vicinity thereof.

FIG. 16c shows a probe 1650 coupled to a plurality of electrodes 1655a-d each in accordance with the present disclosure. The electrodes 1655a-d are arranged in a quadripolar electrode arrangement for interfacingwith a tissue site within the body of a subject. The quadripolarelectrodes 1655 a-d may be arranged so as to allow for muti-site captureof electrophysiological activity on the subject. Such an arrangement maybe advantageous for generating a field vector in the vicinity of theprobe 1650, for mapping electric field propagation across the surface ofthe subject, etc.

FIG. 17 shows aspects of a microfilament array 1725 based surgical tool1700 in accordance with the present disclosure, placed within a urinarybladder 2. The surgical tool 1700 includes a delivery system includingan optional delivery sheath 1705 and a delivery member 1710 inaccordance with the present disclosure configured for passage though theurethra 1 to access the bladder 2. The delivery member 1710 extendsbeyond the sheath 1705 so as to enter the bladder 2 and move thereinduring a procedure. The delivery member 1710 may include an actuate ablepart 1720 configured so as to move, sweep 1755, etc. within the bladder2 for accessing one or more tissues sites along the wall thereof.Protruding from the delivery member 1710 is a microfilament array 1725in including a plurality of microfilament microfingers each inaccordance with the present disclosure. The filament array 1725 may beslide ably deployable 1750 from the delivery member 1710 so as to extendtherefrom and access the tissues for purposes of monitoring, mapping,treating, ablating, delivering a medicament, etc. The microfilaments maybe biased 1751 against the wall of the bladder as part of a procedure.In aspects, the microfilaments 1725 may include sensing tips,electrodes, etc. each in accordance with the present disclosure.

In aspects, the delivery sheath 1705 may accommodate an externallyapplied retention feature 1735, configured so as to maintain a strainrelief fit between the delivery system and the urethra 1 during aprocedure. In aspects, the externally applied retention feature 1735 maybe biased 1770 towards the body of the subject in order to retain thedelivery sheath 1705 in position during a procedure. In aspects, thedelivery member 1710 and/or the delivery sheath 1705 may include one ormore lumens configured for fluid communication 1759 between anexternally located fluid source and the bladder, a restraining balloon1730, or the like.

In aspects, a surgical device in accordance with the present disclosuremay include a means for communicating fluid between the organ and anexternal controller, fluid reservoir, etc. In aspects, the fluid may beheated to a predetermined temperature so as to affect the function(either temporarily, or permanently) of the organ walls during aprocedure. The surgical device may be configured with one or moresensing tips configured to monitor the fluid temperature, tissuetemperature, electrophysiological activity, pressures, etc. within theorgan and/or at sites along the wall of the organ during the procedure.Such a configuration may be advantageous to treat an entire internalwall of an organ with feedback so as to minimize the amount of damagenecessary to achieve the surgical goals of the procedure. In aspects,the fluid may be heated with an electrode setup, an RF heating electrodeconfiguration, an external heater (i.e., with a recirculating fluidtransfer hydraulic circuit to exchange fresh fluid with spent fluidwithin the organ), via magnetic particles in the fluid coupled with anelectromagnetic field to agitate such particles, etc. In aspects, thefluid may include medicament such as a chemotherapy drug, etc. Inaspects, the surgical device may be configured to monitorelectrophysiological activity of a cancerous tumor site to determinewhen a treatment has successfully altered function thereof.

Such a system may be advantageous for treating bladder cancer andoptionally performing hyperthermia based chemotherapy thereof. Inaspects, a system in accordance with the present disclosure may beadvantageous for monitoring/treating cancerous tumors within the body ofthe subject.

Hyperthermia is the targeted application of elevated temperatures incancerous regions to improve the efficacy of traditional treatmentsincluding chemotherapy. In aspects, the fluid may contain iron oxidenanoparticles delivered via catheter as an intravesical ferrofluid tointeract with a magnetic field to heat the fluid during the procedure.The magnetic field may be used to agitate the nanoparticles, causingparticle rotation and magnetic domain realignment, both generating heat.The temperature of the fluid may be elevated by 3-8 degrees celcius aspart of the hyperthermia treatment. In aspects, the chemotherapeuticagent may be methotrexate, vinblastine, doxorubicin, and cisplatin,cisplatin plus fluorouracil (5-FU), mitomycin with 5-FU, Gemcitabine andcisplatin, Methotrexate, vinblastine, doxorubicin (Adriamycin), andcisplatin (called M-VAC), Carboplatin and either paclitaxel ordocetaxel, etc.

In aspects, one or more of the microfilaments 1725 may include one ormore electrodes (i.e., generally at the tip thereof) configured tomonitor a local electrophysiological signal, pass a current i (i.e., astimulating current, an ablating current, a tissue heating current, forpurposes of diagnostics, temporary treatments, permanent treatments,etc.) between one or more of the electrodes with one or more aspects ofthe system and/or a counter electrode 1780 located remotely from thesurgical site (i.e., as a body patch, an electrode inserted into thevagina, the rectum, a transcutaneously placed electrode, etc.). Inaspects, the microfilaments 1725 may be electrically coupled 1760 with aconnector, controller, and/or a microcircuit in accordance with thepresent disclosure.

In aspects, the delivery member 1710 may include one or more sensingtips 1740, 1745 in accordance with the present disclosure to assessand/or treat one or more tissues sites in and around the organ. Somenon-limiting examples are shown including, a strain sensing element1745, and a pressure sensing element 1740. In aspects, the deliverymember 1710 may be configured to bias the microfilament array 1725against the wall of the bladder 2 at an assessment and/or treatment site1440, to monitor such bias force, etc.

Such a tool 1700 may be configured to perform one or more aspects of amethod and/or surgical procedure in accordance with the presentdisclosure.

FIGS. 18a-e show aspects of microfilament tips in accordance with thepresent disclosure. FIG. 18a shows aspects of a microfilament with aconducting, resistive and/or semi-conductive core 1805 (e.g., platinum,carbon, titanium, stainless steel, nickel titanium, silver, gold, springsteel, etc.). In aspects, the core 1805 may be dimensioned with adiameter of less than 100 um, less than 50 um, less than 25 um, lessthan 12 um, less than 7 um, less than 5 um. In aspects, one or moresegments of the core 1805 may be covered with a clad layer 1810.

In aspects, the clad layer 1810 may include a passivating material, ahighly conducting material, a bioactive material, an electricallyinsulating material, etc. In aspects, the clad layer 1810 may beconfigured so as to isolate the core 1805 from the surroundings, toimprove the longitudinal conductivity of the core 1805 (i.e., in thecase of a metallic clad layer 1810), provide unique analyteidentification means (i.e., in the case of a bioactive clad layer 1810,an enzymatic layer, etc.). In aspects, the clad layer 1810 may result ina clad diameter of less than 200 um, less than 100 um, less than 25 um,less than 12 um, less than 6 um, etc. In aspects, the clad layer 1810may be thinner than 1 um, thinner than 0.5 um, thinner than 0.1 um, etc.In aspects, the clad layer 1810 may provide improved opticaltransmission down an optically oriented fiber 1805.

In aspects, one or more segments of the clad layer 1810 or the core 1805may be coated with an insulating layer (or the clad layer 1810 may beinsulating). The insulating layer may include a dielectric material, athick walled polymer material, a ceramic, etc. The insulating layer maybe configured to enhance electrical isolation and/or reduce cross talkbetween microfilaments in a microfilament array in accordance with thepresent disclosure. In aspects, the insulating layer may have a diameterof less than 250 um, less than 200 um, less than 100 um, less than 50um, less than 25 um, less than 10 um, etc. In aspects, the insulatinglayer may be provided with differing thickness (i.e., different overallmicrofilament diameter) along alternative segments thereof. In one nonlimiting example, the insulating layer is relatively thin near to thedistal region of the microfilament but gradually increases in thicknessin the proximal direction thereof.

In aspects, the clad layer 1810 and/or the insulating layer may beremoved and/or otherwise not present over one or more segments of themicrofilament. Such a configuration may be advantageous for altering theflexibility, altering the intercommunication of the microfilaments,allowing for interconnects between microfilaments, etc.

FIG. 18b shows aspects of a microfilament tip including a core 1825 anda clad layer 1830 in accordance with the present disclosure configuredsuch that only the tip of the core 1825 is exposed to the surroundingenvironment during a procedure. Such a configuration may be advantageousfor providing a minimal exposed conducting area of the microfilamentwhile providing isolation along the entire length thereof (i.e., via theclad layer 1830) without profiling or otherwise purposefully shaping thetip thereof.

FIG. 18c shows aspects of a microfilament tip including a core 1850 anda clad layer 1855 in accordance with the present disclosure with agradually increasing thickness for the clad layer 1855.

FIG. 18d shows aspects of a microfilament tip including a core 1870 anda clad layer 1875, the core 1870 wound around 1880 the tip thereof toform an increased electrode area for interfacing with a surroundingtissue site.

FIG. 18e shows aspects of a microfilament as outlined in FIG. 18d withan additional plating or coating procedure 1885 to increase the area, orstrength or to plate the core 1870 or core wound region with anadditional electrode material 1890. In aspects, the additional electrodematerial 1890 may include a conjugated polymer, a metal, a reducedmaterial, etc.

FIG. 19 shows aspects of a microfilament array 1920 based surgical toolin accordance with the present disclosure. The tool includes a deliverymember 1910 including a lumen through which a plurality ofmicrofilaments 1915 is passed. The array 1920 may be slide ably arrangedwithin the delivery member 1910 so as to allow for deployment 1945 ofthe array 1920 therefrom during a deployment procedure.

In aspects, the delivery member 1910 may be actuate able so as to allowfor bending, sweeping, and/or torsional 1930 movement of the array 1920during operation. The delivery member 1910 may include one or morelumens through which are provided tendons for actuating 1940, 1935 thedelivery member 1910 during a procedure.

In aspects, the microfilaments 1915 in the array 1920 may beindividually separated (i.e., not rigidly connected) so as to maintain ahighly flexible structure. In aspects, the microfilament array 1920 maybe enclosed within the delivery member 1910 with a lubricating fluid,the fluid may be an insulating fluid, so as to assist with isolationbetween fibers in the array during use.

FIGS. 20a-c show aspects of a microfilament array based surgical tool inaccordance with the present disclosure. FIG. 20a shows a bundle 2005 formicrofilaments each including a core 2010 and a clad layer 2015 inaccordance with the present disclosure. The tightly packed bundle 2005may be interfaced with a mating connector, microcircuit, or MEMs basedinterconnect in order to extract one or more signals therefrom in adevice.

FIG. 20b illustrates a connector 2020 for interfacing with a microfiberbundle 2030 in accordance with the present disclosure. The microfilamentbundle 2030 may be configured such that individual fibers from thebundle 2030 may be separated out and interfaced with a plurality ofleads 2035 in the body 2025 of the connector. The connector 2020 maythus provide a means for communicating 2040 with the microfilamentbundle 2030 in a system in accordance with the present disclosure.

FIG. 20c illustrates a block connection 2050 of a microfilament bundle2065 in accordance with the present disclosure, the filaments 2060 ofthe microfilament bundle 2065 frozen into a restraining block 2055. Thebundle 2065 and restraining block 2055 may be faced and polished so asto interface with the filaments 2060 therein during use (i.e., bycoupling the polished face with a mating microconnector, etc.).

FIGS. 21a-c show aspects of measurements made over a surface with amicrofilament array based surgical tool in accordance with the presentdisclosure. FIG. 21a shows a schematic of an organ wall 2 and an arrayof contact points 2110 indicating interfacing points created by an arrayof mating sensing tips in accordance with the present disclosureinterfacing with the surface 2105 of the organ wall 2. The plurality ofcontact points 2110 may represent a collection of sites which may besuitable for interacting with the wall, measuring electrophysiologicalactivity on the wall, delivering a current to the wall, etc. In aspects,physiological and/or electrophysiological data may be collected fromeach of the contact points 2110 individually by each of the associatedsensing tips to map the activity over the surface, assess functionalityof the surface, determine which sites may be suitable targets fortreatment, etc.

FIG. 21b shows time series trends of accumulated pressure measured withan array of sensing tips in accordance with the present disclosure. Anindividual trend 2125 obtained from a particular sensing tip within thearray demonstrates the time series pressure experienced by theindividual sensing tip as it is scanned across the organ wall. Anaggregate trend 2130 is also shown obtained by summation of the signalsobtained by all of the sensing tips in the array. In aspects, therelationships between individual trends 2125 and aggregate trends 2130may be advantageous for mapping, determining function along the organwall, identifying abnormal behavior of sites along the wall, determiningpressure and/or electrophysiological wave propagation over the wallduring an event, a test, etc.

FIG. 21c shows an image obtained from a collection of contact points2110 created by an array of sensing tips 2105 in accordance with thepresent disclosure in contact with an anatomical site in the body. Theimage demonstrates propagation of a wave 2115 across the contact points2110 and illustrates the direction of travel of the wave 2120, 2125 toone or more future sites 2130, 2135. The image and location of thecontact points 2110 within the image may be determined from the knowpositioning of sensing tips in a system in accordance with the presentdisclosure (i.e., along the face of a balloon, etc.). In aspects, thepositioning of the sensing tips against the wall may not be known apriori (i.e., in an arrangement with freely moving microfingers,microfilaments, etc.). In aspects, the positioning of sensing tipswithin the array may be, at least partially determined from the sensedsignals, through correlation of wave propagation throughout the arrayduring a monitoring session. In aspects, a wave propagation algorithmmay be used to approximate the positioning of one or more sensing tipsagainst the wall during the monitoring, etc. Other aspects of suchconfigurations are discussed throughout this disclosure.

FIG. 22 shows aspects of a balloon 2205′ based surgical tool inaccordance with the present disclosure including a range of electrodes2225, 2230, 2235, 2240, 2245 for interfacing with a tissue surface. Theballoon 2205′ may be provided in fluid communication 2215 with aspectsof an associated system through a delivery member 2210 attached thereto.Shown in FIG. 22 is a cluster of point electrodes 2235, a pair oftortuous path based electrodes 2240, a pair of tab style electrodes2245, a pair of radially oriented strip electrodes 2230, a collection ofcircumferentially oriented electrodes 1825. In aspects, alternativeelectrode arrangements may be configured for tasks such as formingparticular ablation patterns on the walls, for monitoring differentregions of the balloon, etc.

FIG. 23 shows assessment zones 2320 associated with a balloon baseddevice 2305 in accordance with the present disclosure. The balloon andassociated delivery member 2310 may be provided in fluid communicationand/or electrical communication 2315 between one or more sensing tipslocated in one or more of the regions 2320 with a controller, connector,microcircuit, etc. The grouping of sensing tips into regions 2320 on theballoon may be advantageous for correlating potential treatment siteswith designated regions of the bladder under assessment. As datapertaining to successful outcomes is collected, such regional breakdownof the affected areas will be useful in redesigning the surgical tools,surgical approaches, selecting regions to test, adjusting treatmentcriteria, etc. for the patient population. In aspects, such regions 2320may be broken down into one or more of a region near a middle umbilicalligament, near one or more lateral umbilical ligaments, near to aurethral opening, near the center of Trigone, Rugae, near the neck ofthe bladder, near a sphincter, a urethral sphincter, combinationsthereof, or the like.

FIG. 24 shows aspects of a microfilament based surgical tool in physicalcontact with a tissue site in accordance with the present disclosure.The tool includes a microfilament array 2420 in accordance with thepresent disclosure and a delivery member 2410 through which the array2420 may be coupled 2415 with a controller, etc. The microfilament array2420 is shown biased with a force F_(f) against the wall of an organ 2during a procedure. In aspects, the microfilaments in the array 2420 maybe sufficiently elastic such that the force F_(f) may be highlypredictable. In addition, due to the configuration of the array, eachmicrofilament may reliably contact the organ wall during a procedure.Such an arrangement may be advantageous for maintaining a reliablecontact force between a plurality of contact sites and the wall of theorgan during a procedure.

FIGS. 25a-c show aspects of an implantable device in accordance with thepresent disclosure and a, schematic of an implantable device attachedwithin the inner wall of a urinary bladder. FIG. 25a shows aspects of animplantable device for monitoring and/or modulating neural activityalong the wall of a hollow organ (i.e., a bladder, a uterus, a rectum,etc.) in accordance with the present disclosure. The implantable deviceincludes one or more sensing tips 2520, 2525 each in accordance with thepresent disclosure configured so as to monitor one or physical orphysiological parameters in the vicinity thereof during a surgicalprocedure, following a surgical procedure, during a monitoring session,during a urodynamic procedure, during a patient assessment, etc. Thesensing tips 2520, 2525 are shown as electrodes in this non-limitingexample.

The implantable device includes a housing 2510 including one or moremicrocircuits 2515 configured to monitor signals at the sensing tips2520, 2525, to perform signal conditioning, and to communicate 2535 withan outside reader, controller, operating device, etc. The housing 2510may further include a power source such as a battery, a biofuel cell(i.e., a glucose biofuel cell, a urine based biofuel cell, etc.), or anenergy harvesting subsystem so as to capture kinetic energy, energy froman incident RF signal, or the like. The implantable device includes atail 2530 which may function as a whip antenna for communicating 2535with an external reader, a tether, a removal cord, etc.

In aspects, the implantable device may be configured to monitor neuralactivity, electromyographic information, urodynamics, bladder pressures,and/or physiological information for a period of time following asurgical procedure (i.e., days, weeks, months, indefinitely) followingsuch a procedure. In aspects, the implantable device may performadditional neuromodulation procedures (i.e., RF ablation procedures) inthe case that the neural activity returns to an abnormal state, etc. Inaspects, the power supply may be configured to store sufficient amountsof energy such that the RF ablation procedure may be performed withoutexternal interconnection. Between procedures, the power supply may berecharged, for example via a wireless recharging system, or the like.

FIG. 25b shows an implantable device in accordance with the presentdisclosure placed within a bladder 2 during an extendedmonitoring/treatment session. The implantable device is shown positionednear to the neck of the bladder 2 and anchored to the wall of thebladder via a plurality of hook-like electrodes 2520/2525, in thisnon-limiting example also providing electrode function for monitoringlocal EMG during the monitoring session. In aspects, the implantabledevice may include a pressure sensing tip for monitoring bladderpressures in coordination with the EMG monitoring. The implantabledevice includes a housing 2510 and a whip antenna 2530 for communicating2535 with an externally placed reader, etc. Several potential attachmentsites 2540 a-h are shown located around the walls of the bladder 2.

FIG. 25c shows an implantable device in accordance with the presentdisclosure placed within a bladder 2 during an extendedmonitoring/treatment session. The implantable device is shown positionednear to the neck of the bladder 2 and anchored to the wall of thebladder via a plurality of hook-like electrodes 2555 a,b/2560, in thisnon-limiting example also providing electrode function for monitoringlocal EMG during the monitoring session. In aspects, the implantabledevice may include a pressure sensing tip for monitoring bladderpressures in coordination with the EMG monitoring. The implantabledevice includes a housing 2550 and a tether 2560 for communicating 2575with an externally placed reader, etc. The tether 2560 is electricallyand mechanically coupled with the housing 2550 and arranged so as totraverse the urethra 1, extending to the outside of the body of thesubject. The tether 2560 may include one or more electrodes 2565 a-c forassessing electrophysiological activity within the urethra 1 during amonitoring session. In aspects, the tether 2560 may include an antenna,optionally positioned within a region of the tether 2560 near to thesurface or outside the subject so as to improve the communication rangethereof. In aspects, the tether 2560 may be used to withdraw theimplantable device from the subject after the monitoring session,follow-up, therapy, etc. is completed.

In aspects, the implantable device 2550 may include an external tabhousing 2580 attached to the tether 2560. The tab housing 2580 may beconfigured for easy removal of the implant post procedure, may includeone or more of a power source, an antenna, microelectronics, etc. forcommunicating with the sensing tips included in the housing 2550 whileallowing for a reduction in the size of the implantable portion of thedevice.

In aspects, an implantable device in accordance with the presentdisclosure may include one or more bioadhesives to suitably bond thehousing 2510, 2550 to tissues near a surgical site. Bioadhesives may benon-toxic, non-fouling and biocompatible so as to help minimize theforeign body response during the monitoring process. Some suitablebioadhesives may include polysiloxanes, polyacrylates, polyisocyanatemacromers or mixtures (US Patent Application No. 2008/0339142), fibrinsealants, albumin glue with gluteraldehyde as crosslinker, hydrogelssuch as those formed from chitosan and poly(ethylene glycol) (U.S. Pat.No. 6,602,952), gelatin based adhesive with resorcinol-formaldehydecomplex, oxidized polysaccharides with water-dispersible, multi-armpolyether amine (US Patent Application No. 2006/0078536) among others.The bioadhesives as noted above may also be sufficiently stable so as toretain the implantable device in place during the postoperative recoveryperiod but yet sufficiently biodegradable such that retention is onlymaintained for a reasonable period of time. In the case of a urodynamicmonitoring application, the implantable device may be retained for up to3 weeks, 2 weeks, 1 week, 3 days, or 1 day.

In aspects, the housing 2510, 2550 may include one or more eyeletsadapted so as to accept a suture or staple. Such sutures or staples maybe biodegradable for easy detachment after a known period of retention.Some examples of suitable materials include amino acid based families,polyester urethanes, polyester amides, polyester ureas, polythioesters,and polyesterurethanes.

In aspects, the implantable device or the housing 2510, 2550, mayinclude a coating, a chamber, a release layer, etc. for sustainedrelease of a neuromodulating substance in accordance with the presentdisclosure into the surrounding tissues of the bladder 2. In aspects,the implantable device may include a neuromodulating substance, perhapsconfined in a retaining medium (i.e., a hydrogel matrix, etc.) and thesubstance may leach into the surrounding tissues over time, afterplacement during a surgical procedure. In aspects, the neuromodulatingsubstance may be a potent denervating agent (i.e., a neurotoxin, abotulinum toxin, a tetrodotoxin, a tetraethylammonium, a chlorotoxin, acurare, a conotoxin, a bungarotoxin, arsenic, ammonia, ethanol, hexane,nitric oxide, glutamate, resiniferatoxin, alchohol, phenol, etc.), aneuroblocking agent (i.e., capaicin, an anesthetic, lidocaine, tetanustoxin, quaternary ammonium salts, a pachycurare, a leptocurare,acetylcholine, aminosteroids, etc.).

In aspects, the retaining medium may be configured so as to crosslinkvia a radial polymerization procedure (i.e., photopolymerization), aclick polymerization procedure (i.e., an oxime click chemistry basedhydrogel), or the like. Such form-in-place hydrogels known in the art ofbioscaffold formation and bioadhesives may be adapted for use in thisapplication.

In aspects, the retaining medium may be configured with one or morebiodegradable aspects, such that over time (i.e., in a controlledfashion), the retaining medium may breakdown and further neuromodulatingsubstance may be released into the surrounding tissues.

In aspects, the implantable devices discussed in FIGS. 25a-c may beconfigured to monitor the effect of the neuromodulating substance on thesurrounding tissues over time, for following up on a surgical procedure,etc.

FIG. 26 shows aspects of a system in accordance with the presentdisclosure. The system includes a controller 2610 coupled via one ormore cables, connectors, etc. 2615 with a surgical tool 2620 inaccordance with the present disclosure. The controller 2610 may includeone or more user interfaces through which a user 7 may interact with thesurgical tool 2620 before (i.e., via calibration, testing, etc.), during(i.e., via moving aspects of the tool, monitoring temperatures,impedances, etc.), and/or after a procedure on a subject 6. Thecontroller 2610 may be coupled 2650 (i.e., mechanically or wirelessly)to a display 2630 one or more aspects of the surgical, monitoring, ormapping 2635 process to one or more of the users 7. Aspects of suchfeedback have been discussed throughout the present disclosure.

FIGS. 27a-c show aspects of a system for mapping and/or overlayingphysiological response onto a surgical display during a procedure inaccordance with the present disclosure. FIG. 27a shows aspects of animage 2700 of an anatomical structure 8 (in this case an artery)including a plurality of target tissues 9 a,b (in this case nervesrunning along the artery wall, which may not be visible in a naturallyobtained image). The image 2700 is combined with an augmented realitybased overlay of electrophysiological activity as measured by a surgicaltool 2710 including a plurality of sensing tips (i.e., herein embeddedinto microfilaments 2705) in accordance with the present disclosure. Thesurgical tool 2710 may be configured to indicate electrophysiologicalactivity in the vicinity thereof as it interacts 2715 (i.e., laidagainst, biased towards, swept over, etc.) the tissues. In aspects, theaugmented reality overlay 2720 may be used to help a surgeon determinewhere a treatment should be applied to a surface of the tissues, wherean abnormal tissue site, or physiological function is being measured,etc. As shown, the image includes a series of site ablations 2730 a-dcreated by the surgical tool 2710 and highlighted on the image 2700 fora surgeon to help guide the procedure as it progresses.

FIG. 27b shows an image 2701 including the wall of an organ covered inmicrovasculature 10 based features. Indicated in the image 2701 is aregion 2740 of abnormal activity highlighted for a user and a region2730 under scan with a surgical tool 2710 in accordance with the presentdisclosure. The surgical tool 2710 is being swept 2715 over the surfaceso as to interface a plurality of sensing tips (i.e., herein embeddedinto microfilaments 2705) in accordance with the present disclosure withthe surface for purposes of interfacing therewith.

FIG. 27c shows a region 2730 of a scan highlighting an array of contactpoints 2740 between sensing tips and the tissues site. An overlay ofmacroscopic electrophysiological activity is shown over the region 2730highlighting contours 2755, 2750 formed from the microscopicelectrophysiological signals obtained by the sensing tips. As shown, acontour 2750 indicates a potential source of the activity, which maywarrant treatment, further investigation, etc.

FIG. 28 shows aspects of a system for performing a surgical procedure inaccordance with the present disclosure. The system is shown interfacingwith a surgical site 2801 within a body, a subject, a patient, etc. Thesystem includes a surgical tool 2810 in accordance with the presentdisclosure. During use, the surgical tool 2810 is configured to interact2812 with the surgical site 2801 in accordance with the presentdisclosure. In aspects, the surgical tool 2810 may be coupled to aconnector 2820, the connector providing a mechanical, electrical, and/oroptical interface between the surgical tool 2810 and one or more othermodules of the system. In aspects, the surgical tool 2810 may include anembedded local microcircuit 2815 a (a microcircuit, a switch network, asignal conditioning circuit, etc.) in accordance with the presentdisclosure. In aspects, the connector 2820 may include a localmicrocircuit 2815 b in accordance with the present disclosure. Inaspects, the connector 2820 may be coupled to an operator input device2825 (i.e., a foot pedal, an advancing slider, a torqueing mechanism, arecording button, an ablation button, etc.). In aspects, the connector2820 may be coupled to a control unit 2830 configured to accept one ormore signals from the surgical tool 2810, communicate one or morecontrol signals thereto, send one or more pulsatile and/or radiofrequency signals to the microcontroller, record one or moreelectrophysiological signals from the microsurgical tool, or the like.

In aspects, the control unit 2830 may be connected to a display 2835configured to present one or more aspects of the recorded signalsobtained at least in part with the surgical tool 2810 to an operator, topresent a map, at least partially dependent on the recorded signals, oneor more metrics relating to the monitoring, one or more diagnostic testresults, one or more urodynamic test results, etc.

In aspects, the control unit 2830 may be coupled to a surgical subsystem2840, the surgical subsystem 2840 configured to perform a surgicalprocedure 2845 to the surgical site 2801. Some non-limiting examples ofsuitable surgical procedures include an ablation, a cryoablation, anexcision, a cut, a burn, a radio frequency ablation, radiosurgery, anultrasonic ablation, an abrasion, a biopsy, and delivery of a substance(i.e., a neuromodulating substance in accordance with the presentdisclosure). The control unit 2830 may be configured to influence,direct, control, and/or provide feedback for one or more aspects of thesurgical procedure 2840, based upon one or more of theelectrophysiological signals conveyed by the surgical tool 2810.

Some non-limiting methods for performing a surgical procedure inaccordance with the present disclosure are discussed herein.

In aspects, a method for addressing a surgical site on an organ in abody (e.g., a bowel wall, a stomach, a kidney, a gland, an artery, avein, a renal artery, a kidney, a spleen, a pancreas, a prostate, abladder, etc.) is considered. The method includes, monitoring one ormore local physiological signals (e.g., an evoked potential, aneurological activity, MSNA, EMG, MMG, a local field potential,sympathetic tonal change, etc.) in accordance with the presentdisclosure at one or more measurement locations along a wall of theorgan or an entry port connected thereto to determine one or morereference signals; performing at least a portion of a surgical procedure(e.g., an ablation, an excision, a cryoablation, a cut, a burn, an RFablation, an abrasion, a radiosurgical procedure, a biopsy, delivery ofa substance, etc.) in accordance with the present disclosure at or nearto one or more surgical locations (e.g., proximal, distal, remotelytherefrom, and/or collocated with one or more of the measurementlocations); monitoring one or more local physiological signals at one ormore of the measurement locations to determine one or more updatedsignals; and comparing one or more reference signals with one or moreupdated signals to determine an extent of completion for the surgicalprocedure.

In aspects, the extent of completion may include a change, reductionand/or substantial elimination of at least a portion of one or more ofthe local physiological or electrophysiological signals (e.g., reductionin amplitude of a frequency band, reduction in responsiveness, a changein a lag between measurement locations, a change in cross-talk betweenmeasurement locations, substantial elimination of the signal, etc.).

In aspects, the extent of completion may include measuring a change incoherence between two or more signals obtained from sites affected bythe surgical procedure (i.e., from a first site distal to where thesurgical procedure was performed, and from a second site proximal towhere the surgical procedure was performed in relation to neural trafficmeasured at the sites).

In aspects, the procedure may be to perform a temporary neurologicalblock. In this aspect, the method may be used to separate afferent andefferent traffic from either side of the temporary block, decreasetraffic from affected sensory receptors (i.e., when causing aneurological block to one or more sensory receptors), etc. for furtheranalysis, diagnosis of disease, evaluation of neurological activity orfunctionality, or the like. In aspects, a temporary block may befollowed by a more permanent block if the analysis demonstrates thatsuch a substantially permanent block would be warranted.

In aspects, the step of monitoring to determine an updated signal may beperformed before, during, and/or after the step of performing at least aportion of the surgical procedure. In aspects, monitoring, stimulation,and ablation may be performed in succession and/or in parallel.

In aspects, the method may include sweeping one or more electrodes overthe organ wall while monitoring, stimulating, and/or ablating thesurface thereof. In aspects, simultaneous monitoring and sweeping may beused to generate a map of neurological activity along the organ wall. Inaspects, the method may include penetrating or embedding one or moreelectrodes into the organ wall, so as to isolate the electrodes from thelumen thereof.

The step of performing at least a portion of the surgical procedure maybe repeated. Thus aspects of the method may be incrementally applied, soas to head towards completion in a stepwise process without excessiveapplication of the surgical procedure.

The method may include waiting after performing at least a portion ofthe surgical procedure. Monitoring may be performed during the waitingprocedure, perhaps so as to determine a recovery period for the localphysiological signal (i.e., a time period over which the localphysiological signal recovers). Such a recovery period may be anindication of the extent of completion.

In aspects, the method may include stimulating one or more stimulationlocations (proximal, distal, remotely therefrom, and/or collocated withone or more of the measurement locations and/or the surgical locations).The step of stimulating may be coordinated with the step of performingat least a portion of the surgical procedure, and/or with the step ofmonitoring to determine a reference and/or updated signal. Thestimulation may be provided in any form in accordance with the presentdisclosure. In aspects, the stimulation may include one or more currentpulses, one or more voltage pulses, combinations thereof, or the like.The step of stimulation may be advantageous for assessing the updatedsignal at one or more measurement locations and/or between two or moremeasurement locations in the presence of background noise and/or localphysiological activity.

In aspects, the method may include monitoring one or more remotephysiological parameters in accordance with the present disclosure at aremote location (e.g., in the vicinity of an alternative organ, siteassociated with a related biological process, an organ, a ganglion, anerve, etc.) substantially removed from the immediate vicinity of thesurgical site to determine an updated remote physiological signal and/orreference remote physiological signal.

Some non-limiting examples of remote physiological parameters that maybe monitored include water concentration, tone, blood oxygen saturationof local tissues, evoked potential, stimulation/sensing of nervousactivity, local field potential, electromyography, temperature, bloodpressure, vasodialation, vessel wall stiffness, muscle sympathetic nerveactivity (MSNA), central sympathetic drive (e.g., bursts per minute,bursts per heartbeat, etc.), tissue tone, blood flow (e.g., through anartery, through a renal artery), a blood flow differential signal (e.g.,a significantly abnormal and or sudden change in blood flow within astructure of the body, a vessel, an organ, etc.), blood perfusion (e.g.,to an organ, an eye, etc.), a blood analyte level (e.g., a hormoneconcentration, norepinephrine, catecholamine, renine, angiotensin II, anion concentration, a water level, an oxygen level, etc.), nerve traffic(e.g., post ganglionic nerve traffic in the peroneal nerve, celiacganglion, superior mesenteric ganglion, aorticorenal ganglion, renalganglion, and/or related nervous system structures), combinationsthereof; and the like.

The updated remote physiological signal and/or reference remotephysiological signal may be combined and/or compared with one or morereference signals, and/or one or more updated signals in order todetermine the extent of completion of a surgical procedure, as part of adecision making process, and/or as part of a surgical control system(i.e., so as to determine whether to continue with, stop, or alter thesurgical procedure).

In aspects, the method may include selecting a surgical location. Thestep of selection may depend upon one or more monitoring steps,proximity to an alternative surgical location (i.e., perhaps apreviously treated surgical location, a prospected surgical location,etc.).

In aspects, the method may include sweeping the lumen and/or wall of avessel while monitoring in order to localize one or more anatomicalsites of interest, one or more regions of abnormal activity, etc.

In aspects, the steps of monitoring, comparing, analyzing, diagnosing,and/or treating may be completed sequentially. Alternatively,additionally, or in combination, the steps of monitoring may beeffectively continuously applied through the procedure. The comparisonmay be made using one or more data points obtained from one or moresteps of monitoring. The comparison may be made via algorithmiccombination of one or more measurements.

In aspects, the step of monitoring may be used to extract one or moreelectrophysiological parameters during a first period and monitoring anapplied field (i.e., as caused by a stimulation and/or ablation event)during a second period.

In aspects, the method may include generating a topographical map fromthe one or more measurements (e.g., from one or more of the signals).The method may include determining a topographical map of physiologicalfunctionality in the vicinity of the surgical site derived from one ormore of the physiological signals. The method may include updating thetopographical map after the step of performing at least a portion of thesurgical procedure. The method may include generating the map during asweeping process (i.e., a longitudinal sweep, a circumferential sweep, ahelical sweep, etc.).

In aspects, the method may include placement of a plurality of surgicaltools, one or more surgical tools (i.e., a procedural tool) placed so asto access one or more of the surgical locations, and one or moresurgical tools (i.e., a monitoring tool) placed so as to access one ormore of the monitoring locations. In one non-limiting example, aprocedural tool may be placed upon a first organ (e.g., a bladder wall,a bowel wall, a stomach wall, a kidney, a gland, a renal artery, a leftrenal artery, etc.) and a monitoring tool may be placed upon a secondorgan (e.g., an opposing renal artery, a right renal artery, a femoralartery, an iliac artery, a vagina, a uterus, a rectum, in the vicinityof a sacrum, etc.). Thus, the monitoring tool may be used to monitor oneor more of the measurement locations on the second organ. The proceduraltool may be used to surgically treat one or more surgical locations onthe first organ. Additionally, alternatively, or in combination, theprocedural tool may monitor one or more monitoring locations on thefirst organ, perhaps in combination with monitoring performed on thesecond organ by the monitoring tool.

In aspects, the method may be performed with one or more surgical toolsin accordance with the present disclosure.

One or more steps of monitoring may be performed with one or moresensing tips in accordance with the present disclosure.

One or more steps of performing at least a portion of the surgicalprocedure may be performed with one or more sensing tips in accordancewith the present disclosure.

In aspects, a method for RF ablating tissue is provided. During such amethod, the local tissue tone may be measured before, during, betweenindividual RF pulses, and/or after a train of RF pulses. As the localtissue tone changes during application of the RF pulses, the tonalchanges may be used to determine the extent of the therapy. As the RFablation process is applied to the adjacent tissues (perhaps via one ormore sensing tips), the tonal measurements (as determined by one or moresensing tips, perhaps the same tip through which the RF signal may beapplied) may be monitored to determine an extent of completion of theprocedure. Such an approach may be advantageous as the tonal measurementtechniques may not be significantly affected by the local RF currentsassociated with the RF ablation procedure.

In aspects, an interventionalist/proceduralist may insert a catheter inaccordance with the present disclosure into the urethra so as tocannulate the bladder. In aspects, a guiding catheter may be used forthis purpose, and to form a stable reference through which to deliverone or more surgical tools. In aspects, a surgical tool in accordancewith the present disclosure may be placed through the guiding catheter.

In aspects, an interventionalist/proceduralist may insert a surgicaltool in accordance with the present disclosure via a percutaneousapproach, perhaps under guidance with a visualization aid (i.e.,ultrasound guidance, radiosurgical guidance, etc.) so as to approach theintended organ from an alternative direction. In aspects, a combinationof urethral and percutaneous approaches may be coordinated (i.e., in thecase of multi-tool procedures).

In aspects, the electrodes may be configured and dimensioned so as topenetrate into the organ wall upon biased there against. The electrodesmay be forced to cause penetration of one or more of the electrodes intothe intima, mucosa, submucosa, transitional epithelium, muscular layers,detrusor muscle, longitudinal muscle layer, circular muscle layer,adventitia, peritoneum, of the organ wall (i.e., bladder, uterus, etc.)or adventitia in the vicinity thereof to be measured. In aspects, one ormore electrodes may be configured for microscopic or macroscopic spatialrecording. In aspects, a plurality of microscopically configuredelectrodes may be used to generate one or more macroscopic spatialrecordings from a collection of microscopic spatial recordings.Following a suitable period of recording, the device may be withdrawninto the guiding catheter and removed from the body.

In aspects, a substrate, balloon wall, microfinger, filament, etc. inaccordance with the present disclosure including/supporting apenetrating electrode, may include one or more features configured so asto limit the penetration depth thereof into the wall during such aprocedure. In aspects, such depth limiting features may include apartition, a flange, a bump, a collar, a step in diameter (i.e., in thecase of a microfinger, or filament, etc.), combinations thereof, or thelike. In aspects, a balloon wall or substrate mounted penetratingelectrode may be configured so as to limit the depth of penetration intoan adjacent tissue surface via the embossed height of the electrodebeyond the balloon wall or substrate itself (i.e., the needle height,embossed height, etc.).

It will be appreciated that additional advantages and modifications willreadily occur to those skilled in the art. Therefore, the disclosurespresented herein and broader aspects thereof are not limited to thespecific details and representative embodiments shown and describedherein. Accordingly, many modifications, equivalents, and improvementsmay be included without departing from the spirit or scope of thegeneral inventive concept as defined by the appended claims and theirequivalents.

What is claimed is:
 1. An apparatus, comprising: an elongate deliverymember configured to be inserted into a bladder through a urethra; atherapy delivery element coupled with the elongate delivery member, thetherapy delivery element being configured to interface with a tissue ina target region of a bladder wall to provide therapy to the targetregion; one or more sensing tips electrically and mechanically coupledwith the elongate delivery member, the sensing tips being configured tointerface with one or more tissue surfaces of at least one of thebladder wall and the urethra, the sensing tips configured to convey oneor more electrophysiological signals associated with the tissue surfacesat least one of before, during, and after the therapy; wherein theapparatus is configured to neuromodulate bladder function; wherein agiven one of the sensing tips comprises: one or more electrodes on atissue-interfacing surface thereof; and a degradable support structureconfigured to dissolve in the presence of a liquid; wherein thedegradable support structure is arranged relative to thetissue-interfacing surface of the given sensing tip such that thedegradable support structure when placed beside the bladder wall andwetted dissolves to cause one or more of the electrodes on thetissue-interfacing surface of the given sensing tip to contact thebladder wall; and a housing configured for implantation inside thebladder, the housing comprising one or more microcircuits, an antennaand at least one of the sensing tips, the one or more microcircuitsconfigured: to monitor electrophysiological signals at said at least onesensing tip; to perform signal conditioning of the monitoredelectrophysiological signals; and to convey the conditionedelectrophysiological signals to an external reader outside the bladderutilizing the antenna; wherein the housing comprises a coating, thecoating comprising a neuromodulating substance in a biodegradableretaining medium, the biodegradable retaining medium configured toprovide controlled release of the neuromodulating substance into thetissue in the target region of the bladder wall.
 2. The apparatus ofclaim 1, wherein the one or more electrophysiological signals arerelated to one or more of a water concentration, a tissue tone, anevoked potential, a remotely stimulated nervous activity, a pressurestimulated nervous response, an electrically stimulated movement, asympathetic nervous activity, an electromyographic signal [EMG], amechanomyographic signal [MMG], a local field potential, anelectroacoustic event, a vasodialation, a bladder wall stiffness, amuscle sympathetic nerve activity [MSNA], a central sympathetic drive, anerve traffic, or combinations thereof.
 3. The apparatus of claim 1,wherein at least one of the one or more the sensing tips comprises thetherapy delivery element.
 4. The apparatus of claim 1, wherein one ormore of the electrodes on the tissue-interfacing surface of the at leastone sensing tip comprises at least one of an embossed, a plated, and afilament loaded structure thereupon configured to protrude into theassociated tissue surface when biased there against.
 5. The apparatus ofclaim 1, wherein the sensing tips comprises a plurality of sensing tipsarranged in a networked array, the sensing tips being configured tomeasure the one or more electrophysiological signals associated with thetissue surfaces before, during and/or after the therapy, and wherein themicrocircuit is electrically coupled to the networked array of sensingtips, and wherein the microcircuit is configured to multiplex signalsfrom the networked array of sensing tips prior to conveying theconditioned electrophysiological signals to the external reader.
 6. Theapparatus of claim 5, wherein the microcircuit is locally placedproximate to the networked array of sensing tips, the microcircuit beingconfigured to communicate with the networked array of sensing tips andthe extracorporeal system via digital signals such that the microcircuitis configured to exchange data pertaining to selected ones of theplurality of sensing tips in the networked array, switch data, controldata and radio frequency pulse routing.
 7. The apparatus of claim 1,wherein at least one of the one or more sensing tips comprises at leastone of one or more needle electrodes and one or more whiskers, eachhaving a characteristic length and a tip and being arranged so as toextend from the sensing tip into the associated tissue surface.
 8. Theapparatus of claim 1, wherein at least one of the one or more sensingtips comprises at least one of a mechanomyographic (MMG) sensing elementconfigured to generate a mechanomyographic signal (MMG) from theassociated tissue surface, and a compliance sensor configured togenerate a tissue tone signal.
 9. The apparatus of claim 1, wherein atleast one of the one or more sensing tips comprises a microelectrodeconfigured to interface with the associated tissue surface, themicroelectrode having an area of less than 5000 um², less than 1000 um²,less than 250 um², or less than 100 um².
 10. The apparatus of claim 1,wherein at least one of the one or more sensing tips and the therapydelivery element are configured to at least one of electricallystimulate and ablate at least one of the associated tissue surface andtarget region respectively.
 11. The apparatus of claim 1, wherein atleast one of the one or more sensing tips and the therapy deliveryelement are configured to at least one of mechanically stimulate andablate at least one of the associated tissue surface and target regionrespectively.
 12. The apparatus of claim 1, wherein the therapy deliveryelement is configured to deliver a therapeutic substance to the targetregion.
 13. The apparatus of claim 12, wherein at least one of the oneor more sensing tips is configured to monitor the effect of thetherapeutic substance on the target region.
 14. The apparatus of claim12, wherein the therapeutic substance is selected from a chemical, adrug substance, a neuromodulating substance, a neuroblocking substance,an acid, a base, a denervating agent, or a combination thereof.
 15. Theapparatus of claim 12, wherein the therapeutic substance is a selectedfrom a neurotoxin, a botulinum toxin, a tetrodotoxin, atetraethylammonium, a chlorotoxin, a curare, a conotoxin, abungarotoxin, arsenic, ammonia, ethanol, hexane, nitric oxide,glutamate, resiniferatoxin, an alcohol, a phenol, capaicin, ananesthetic, lidocaine, tetanus toxin, quaternary ammonium salts, apachycurare, a leptocurare, acetylcholine, aminosteroids, or acombination thereof.
 16. The apparatus of claim 1, wherein the therapydelivery element is configured to modulate at least one of micturition,incontinence, frequency, pain, nocturia, and bladder capacity.
 17. Theapparatus of claim 1, wherein the given sensing tip comprises ahook-shaped structure having one or more of the electrodes placed on aninner surface of the hook-shaped structure.
 18. The apparatus of claim1, wherein the tissue-interfacing surface of the given sensing tip isconfigured to contour to a given portion of the tissue surface of thebladder wall, the one or more electrodes on the tissue-interfacingsurface being configured to read local neurological signals withoutinterfering mechanically with signal transmission of the localneurological signals.
 19. The apparatus of claim 1, wherein thetissue-interfacing surface of the given sensing tip comprise abioadhesive configured to bond the tissue-interfacing surface to thebladder wall, the bioadhesive being biodegradable such that thetissue-interfacing surface bonds to the bladder wall for a limitedperiod of time.
 20. The method of claim 1, wherein at least a given oneof the electrodes on the tissue-interfacing surface of the given sensingtip comprises a whisker structure extending from the given electrode.21. The method of claim 20, wherein the whisker structure comprises acarbon structure.
 22. The method of claim 21, wherein the carbonstructure comprises a carbon fiber.
 23. The method of claim 21, whereinthe carbon structure comprises a carbon nanotube.
 24. The method ofclaim 20, wherein the whisker structure is insulated along a portion ofits length and has an electrically exposed region at a tip thereof. 25.The method of claim 20, wherein the whisker structure is configured withsufficient strength to penetrate into the tissue surface of the bladderwall.